FDA Product Code
FDA Product Code DTZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4350
510(k) Clearances — 255 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | 2026-09-14 | Traditional | PDF ↗ |
| K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | 2026-03-16 | Traditional | PDF ↗ |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical S.R.L. | 2026-03-12 | Traditional | PDF ↗ |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L | 2025-12-12 | Traditional | PDF ↗ |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | 2025-11-24 | Traditional | PDF ↗ |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L | 2024-09-12 | Traditional | PDF ↗ |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | Medtronic Perfusion Systems | 2024-07-10 | Traditional | PDF ↗ |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | 2024-06-12 | Special | PDF ↗ |
| K231652 | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | 2023-11-16 | Special | PDF ↗ |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Qura S.R.L | 2023-11-08 | Traditional | PDF ↗ |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. | 2023-11-01 | Traditional | PDF ↗ |
| K230640 | Affinity Fusion Oxygenator System | Medtronic, Inc. | 2023-04-06 | Special | PDF ↗ |
| K223161 | OXY-1 System | Abiomed, Inc. | 2023-02-23 | Traditional | PDF ↗ |
| K222297 | CentriMag Pre-connected Pack | Abbott | 2022-12-01 | Traditional | PDF ↗ |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | Qura S.R.L | 2022-01-28 | Traditional | PDF ↗ |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | Qura S.R.L | 2021-12-17 | Traditional | PDF ↗ |
| K202510 | AMG PMP Infant | Eurosets S.R.L | 2021-12-10 | Traditional | PDF ↗ |
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Medtronic | 2021-09-16 | Traditional | PDF ↗ |
| K211495 | EOS PMP | Sorin Group Italia S.R.L. | 2021-07-12 | Special | PDF ↗ |
| K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021-04-01 | Traditional | PDF ↗ |
| K200109 | OXY-1 System | Abiomed, Inc. | 2020-10-23 | Traditional | PDF ↗ |
| K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | Chalice Medical , Ltd. | 2020-09-18 | Traditional | PDF ↗ |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | Sorin Group Italia S.R.L. | 2020-08-13 | Special | PDF ↗ |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir | Sorin Group Italia S.R.L. | 2020-06-12 | Special | PDF ↗ |
| K191246 | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | Chalice Medical , Ltd. | 2020-02-28 | Traditional | PDF ↗ |
| K191444 | Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir | Medtronic, Inc. | 2019-09-27 | Traditional | PDF ↗ |
| K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac | Medtronic, Inc. | 2019-05-17 | Special | PDF ↗ |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | Sorin Group Italia S.R.L. | 2019-04-13 | Special | PDF ↗ |
| K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | Medtronic, Inc. | 2019-04-12 | Traditional | PDF ↗ |
| K183511 | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) | Medtronic, Inc. | 2019-03-18 | Traditional | PDF ↗ |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) | Terumo Cardiovascular Systems Corporation | 2018-06-22 | Traditional | PDF ↗ |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) | Terumo Cardiovascular Systems Corporation | 2018-03-29 | Traditional | PDF ↗ |
| K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter | Sorin Group Italia S.R.L. | 2018-03-15 | Special | PDF ↗ |
| K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface | Medtronic, Inc. | 2017-11-20 | Traditional | PDF ↗ |
| K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir | Medtronic, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K162896 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface | Medtronic, Inc. | 2016-12-06 | Traditional | PDF ↗ |
| K162016 | Affinity NT Oxygenator with Cortiva BioActive Surface | Medtronic, Inc. | 2016-09-21 | Traditional | PDF ↗ |
| K153295 | TandemLung Oxygenator | Cardiacassist, Inc. | 2016-02-26 | Traditional | PDF ↗ |
| K153213 | Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-12-03 | Special | PDF ↗ |
| K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating | Terumo Cardiovascular Systems Corp. | 2015-12-02 | Special | PDF ↗ |
| K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir | Terumo Cardiovascular Systems Corporation | 2015-11-19 | Special | PDF ↗ |
| K151713 | LILLIPUP PMP, LILLIPUT PMP INTEGRATED | Sorin Group Italia S.R.L. | 2015-11-06 | Traditional | PDF ↗ |
| K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-20 | Traditional | PDF ↗ |
| K150489 | EOS PMP, EOS PMP Integrated | Sorin Group Italia S.R.L. | 2015-06-11 | Traditional | PDF ↗ |
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | Maquet Cardiopulmonary, AG | 2015-05-07 | Traditional | PDF ↗ |
| K143073 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface | Medtronic, Inc. | 2015-03-25 | Traditional | PDF ↗ |
| K141492 | ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) | Eurosets S.R.L | 2015-02-06 | Traditional | PDF ↗ |
| K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface | Medtronic, Inc. | 2014-10-24 | Special | PDF ↗ |
| K140774 | TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | Terumo Cardiovascular Systems Corporation | 2014-06-02 | Traditional | PDF ↗ |
| K140181 | MEDOS HILITE INFANT OXYGENATOR | Medos Medizintechnik AG | 2014-02-19 | Special | PDF ↗ |
| K140177 | MEDOS HILITE OXYGENATOR | Medos Medizintechnik AG | 2014-02-18 | Special | PDF ↗ |
| K133261 | MEDOS HILITE 7000 & 7000 LT OXYGENATOR | Medos Medizintechnik AG | 2014-01-09 | Special | PDF ↗ |
| K132829 | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS | Maquet Cardiopulmonary, AG | 2013-10-08 | Special | PDF ↗ |
| K130433 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE | Sorin Group Italia S.R.L. | 2013-03-20 | Special | PDF ↗ |
| K130493 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR | Terumo Corporation | 2013-03-13 | Special | PDF ↗ |
| K130359 | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA | Terumo Cardiovascular Systems Corp. | 2013-03-13 | Special | PDF ↗ |
| K130280 | CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR | Terumo Corporation | 2013-03-13 | Special | PDF ↗ |
| K130520 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | Ashitaka Factory of Terumo Corp. | 2013-03-13 | Special | PDF ↗ |
| K130333 | CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR | Terumo Cardiovascular Systems Corp. | 2013-03-13 | Special | PDF ↗ |
| K130209 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED | Sorin Group Italia S.R.L. | 2013-02-12 | Special | PDF ↗ |
| K123314 | AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE | Medtronic, Inc. | 2013-01-22 | Traditional | PDF ↗ |
| K122827 | AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 | Medtronic, Inc. | 2012-12-14 | Traditional | PDF ↗ |
| K122844 | INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR | Sorin Group Italia S.R.L. | 2012-10-17 | Special | PDF ↗ |
| K100645 | AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE | Medtronic, Inc. | 2012-09-14 | Traditional | PDF ↗ |
| K122254 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | Sorin Group Italia S.R.L. | 2012-08-24 | Special | PDF ↗ |
| K121536 | INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR | Sorin Group Italia S.R.L. | 2012-08-22 | Traditional | PDF ↗ |
| K121909 | INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR | Sorin Group Italia S.R.L. | 2012-07-26 | Special | PDF ↗ |
| K121229 | INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY | Sorin Group Italia S.R.L. | 2012-07-23 | Traditional | PDF ↗ |
| K120185 | INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR | Sorin Group Italia S.R.L. | 2012-05-11 | Traditional | PDF ↗ |
| K113626 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | Sorin Group Italia S.R.L. | 2012-04-05 | Traditional | PDF ↗ |
| K112360 | QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES | Maquet Cardiopulmonary, AG | 2011-09-15 | Special | PDF ↗ |
| K103191 | QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING | Maquet Cardiopulmonary, AG | 2011-03-08 | Traditional | PDF ↗ |
| K102464 | QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING | Maquet Cardiopulmonary, AG | 2011-03-04 | Traditional | PDF ↗ |
| K102109 | ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 | Eurosets S.R.L | 2011-02-15 | Traditional | PDF ↗ |
| K101153 | QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD | Maquet Cardiopulmonary, AG | 2010-12-08 | Traditional | PDF ↗ |
| K100278 | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA | Maquet Cardiopulmonary, AG | 2010-04-30 | Traditional | PDF ↗ |
| K093522 | QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C | Maquet Cardiopulmonary, AG | 2009-12-07 | Special | PDF ↗ |
| K090689 | QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 | Maquet Cardiopulmonary, AG | 2009-10-29 | Traditional | PDF ↗ |
| K092895 | APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Sorin Group Italia S.R.L. | 2009-10-19 | Special | PDF ↗ |
| K090450 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT | Gish Biomedical, Inc. | 2009-09-18 | Traditional | PDF ↗ |
| K090449 | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT | Gish Biomedical, Inc. | 2009-09-18 | Traditional | PDF ↗ |
| K090511 | QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 | Maquet Cardiopulmonary, AG | 2009-06-12 | Special | PDF ↗ |
| K082403 | MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT | Gish Biomedical, Inc. | 2009-05-15 | Traditional | PDF ↗ |
| K082117 | QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 | Maquet Cardiopulmonary, AG | 2009-02-18 | Traditional | PDF ↗ |
| K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING | Gish Biomedical, Inc. | 2009-02-02 | Traditional | PDF ↗ |
| K083021 | APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Sorin Group Italia S.R.L. | 2008-10-29 | Special | PDF ↗ |
| K073380 | SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI | Sorin Group Italia S.R.L. | 2008-02-29 | Traditional | PDF ↗ |
| K071774 | JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 | Maquet Cardiopulmonary, AG | 2008-01-23 | Traditional | PDF ↗ |
| K072091 | D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR | Sorin Group Italia S.R.L. | 2007-10-29 | Abbreviated | PDF ↗ |
| K072362 | NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG | Novalung GmbH | 2007-10-23 | Traditional | PDF ↗ |
| K071572 | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER | Terumo Corp. | 2007-07-23 | Traditional | PDF ↗ |
| K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | Terumo Corp. | 2007-07-16 | Traditional | PDF ↗ |
| K062381 | CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR | Terumo Cardiovascular Systems Corp. | 2006-08-24 | Traditional | PDF ↗ |
| K061628 | JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 | Maquet Cardiopulmonary, AG | 2006-08-22 | Traditional | PDF ↗ |
| K061031 | D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W | Sorin Group Italia S.R.L. | 2006-06-02 | Special | PDF ↗ |
| K051997 | CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR | Terumo Cardiovascular Systems Corp. | 2005-09-15 | Traditional | PDF ↗ |
| K050447 | PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Dideco S.R.L. | 2005-03-08 | Special | PDF ↗ |
| K043323 | D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | Dideco S.R.L. | 2005-02-01 | Abbreviated | PDF ↗ |
| K040210 | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR | Terumo Corp. | 2004-03-03 | Traditional | PDF ↗ |
| K031903 | RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 | Guidant Corporation | 2004-03-03 | Traditional | PDF ↗ |
Product code DTZ · Class II · Cardiovascular. Data: openFDA.