FDA Product Code
FDA Product Code KRD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3300
510(k) Clearances — 132 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 | Traditional | PDF ↗ |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026-07-24 | Traditional | PDF ↗ |
| K261866 | Concerto Versa Detachable Coil | Medtronic, Inc. | 2026-06-24 | Special | PDF ↗ |
| K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | 2026-06-12 | Traditional | PDF ↗ |
| K260508 | LOBO Vascular Occlusion System | Okami Medical, Inc. | 2026-04-10 | Traditional | PDF ↗ |
| K253511 | Concerto Versa Detachable Coil | Medtronic, Inc. | 2026-01-14 | Traditional | PDF ↗ |
| K253677 | Tembo Embolic System | Instylla, Inc. | 2025-12-15 | Special | PDF ↗ |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation | 2025-10-30 | Special | PDF ↗ |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | 2025-09-23 | Traditional | PDF ↗ |
| K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | 2025-07-09 | Traditional | PDF ↗ |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | 2025-05-30 | Special | PDF ↗ |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 2025-05-16 | Traditional | PDF ↗ |
| K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | 2025-05-15 | Traditional | PDF ↗ |
| K250079 | Ruby XL System | Penumbra, Inc. | 2025-03-14 | Traditional | PDF ↗ |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025-01-17 | Traditional | PDF ↗ |
| K240873 | TEMBO Embolic System | Instylla, Inc. | 2024-12-16 | Traditional | PDF ↗ |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | 2024-10-16 | Special | PDF ↗ |
| K242507 | OBSIDIO Conformable Embolic | Boston Scientific | 2024-10-03 | Special | PDF ↗ |
| K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024-05-30 | Traditional | PDF ↗ |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. | 2024-05-02 | Traditional | PDF ↗ |
| K234123 | Easi-Vue® embolic microspheres System | Abk Biomedical, Inc. | 2024-02-13 | Traditional | PDF ↗ |
| K231554 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2023-11-14 | Traditional | PDF ↗ |
| K230706 | EMBOLD Soft Detachable Coil System | Boston Scientific Corporation | 2023-06-27 | Traditional | PDF ↗ |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | MicroVention, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K220567 | Easi-Vue embolic microspheres System | Abk Biomedical, Inc. | 2022-09-07 | Traditional | PDF ↗ |
| K213385 | GEM | Obsidio, Inc. | 2022-07-01 | Traditional | PDF ↗ |
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | Okami Medical | 2022-04-29 | Traditional | PDF ↗ |
| K213398 | EMBOLD Fibered Detachable Coil System | Boston Scientific Corporation | 2022-04-12 | Traditional | PDF ↗ |
| K220699 | Prestige Coil System | Bait USA, LLC | 2022-04-08 | Special | PDF ↗ |
| K213200 | Solus Gold Embolization Device | Artio Medical, Inc. | 2022-03-21 | Traditional | PDF ↗ |
| K212057 | Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS | Artventive Medical Group, Inc. | 2022-03-01 | Traditional | PDF ↗ |
| K212817 | Merit Siege Vascular Plug | Merit Medical System, Inc. | 2021-12-15 | Traditional | PDF ↗ |
| K210562 | HRSpheres Narrow-Size Embolic Microspheres | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2021-10-01 | Traditional | PDF ↗ |
| K202850 | Concerto Versa, Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-02-09 | Traditional | PDF ↗ |
| K203025 | LOBO Vascular Occlusion System (model LOBO-5) | Okami Medical | 2020-11-05 | Special | PDF ↗ |
| K191680 | AZUR Vascular Plug | MicroVention, Inc. | 2020-03-20 | Traditional | PDF ↗ |
| K200083 | EMBA Hourglass Peripheral Embolization Device (PED) | Embolic Acceleration, LLC | 2020-02-14 | Special | PDF ↗ |
| K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization Devices | C.R. Bard, Inc. | 2020-02-04 | Traditional | PDF ↗ |
| K192480 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | 2019-11-21 | Traditional | PDF ↗ |
| K192083 | Okami Medical LOBO Vascular Occlusion System | Okami Medical | 2019-10-30 | Traditional | PDF ↗ |
| K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019-08-06 | Traditional | PDF ↗ |
| K183578 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | 2019-06-18 | Traditional | PDF ↗ |
| K182390 | IMPEDE-FX Embolization Plug | Shape Memory Medical | 2019-05-23 | Traditional | PDF ↗ |
| K182944 | Dr. Amplatz Micro Plug | Ka Medical, LLC | 2019-04-17 | Traditional | PDF ↗ |
| K181021 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2018-09-27 | Traditional | PDF ↗ |
| K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018-07-16 | Traditional | PDF ↗ |
| K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm | Shape Memory Medical | 2018-06-22 | Traditional | PDF ↗ |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | Vascular Solutions, Inc. | 2018-01-19 | Special | PDF ↗ |
| K171946 | Gel-Bead | Vascular Solutions, Inc. | 2017-10-25 | Special | PDF ↗ |
| K172372 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2017-09-06 | Special | PDF ↗ |
| K171845 | EMBA Hourglass Peripheral Embolization Device | Emba Medical Limited | 2017-08-18 | Traditional | PDF ↗ |
| K162524 | AZUR CX Detachable 18 Peripheral Coil System | MicroVention, Inc. | 2017-03-03 | Traditional | PDF ↗ |
| K162373 | LC Bead LUMI | Biocompatibles UK Limited | 2016-12-16 | Traditional | PDF ↗ |
| K160219 | Hilal Embolization MicroCoils | Cook Incorporated | 2016-08-03 | Traditional | PDF ↗ |
| K153778 | Nester Embolization Coils, Tornado Embolization Coils | Cook Incorporated | 2016-05-19 | Traditional | PDF ↗ |
| K150876 | Bead Block | Biocompatibles UK , Ltd. | 2016-03-07 | Traditional | PDF ↗ |
| K150870 | HydroPearl Microspheres, HydroPearl Microspheres | MicroVention, Inc. | 2015-12-21 | Traditional | PDF ↗ |
| K150964 | MReye Flipper Detachable Embolization Coil and Delivery System | Cook Incorporated | 2015-12-18 | Traditional | PDF ↗ |
| K150931 | MReye Embolization Coils | Cook Incorporated | 2015-12-18 | Traditional | PDF ↗ |
| K152157 | LC Bead LUMI | Biocompatibles UK , Ltd. | 2015-12-11 | Traditional | PDF ↗ |
| K153102 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2015-11-23 | Special | PDF ↗ |
| K151358 | AZUR CX Detachable 35 Coils | MicroVention, Inc. | 2015-09-25 | Traditional | PDF ↗ |
| K150402 | Endoluminal Occlusion System-EOS | Artventive Medical Group, Inc. | 2015-09-25 | Traditional | PDF ↗ |
| K150958 | LifePearl Microshperes | MicroVention, Inc. | 2015-09-17 | Traditional | PDF ↗ |
| K151187 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2015-07-27 | Traditional | PDF ↗ |
| K151676 | Retracta Detachable Embolization Coil | Cook Incorporated | 2015-07-22 | Special | PDF ↗ |
| K150108 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2015-04-22 | Special | PDF ↗ |
| K133924 | ENDOLUMINAL OCCLUSION SYSTEM (EOS) | Artventive Medical Group, Inc. | 2014-12-03 | Abbreviated | PDF ↗ |
| K140796 | MEDUSA VASCULAR PLUG, | Endoshape, Inc. | 2014-12-02 | Traditional | PDF ↗ |
| K143038 | Gel-Block 10X embolization pledgets | Vascular Solutions, Inc. | 2014-11-20 | Special | PDF ↗ |
| K141378 | IDC INTERLOCKING DETACHABLE COIL | Boston Scientific Corporation | 2014-10-08 | Traditional | PDF ↗ |
| K141209 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES | Celonova Biosciences, Inc. | 2014-08-07 | Traditional | PDF ↗ |
| K141313 | REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM | Reverse Medical Corporation | 2014-06-18 | Special | PDF ↗ |
| K133237 | GEL-BEAD EMBOLIZATION SPHERES | Vascular Solutions, Inc. | 2014-04-25 | Traditional | PDF ↗ |
| K133626 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | MicroVention, Inc. | 2013-12-20 | Special | PDF ↗ |
| K133282 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | Reverse Medical Corporation | 2013-11-27 | Special | PDF ↗ |
| K133208 | INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corp | 2013-11-14 | Special | PDF ↗ |
| K132083 | AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 | MicroVention, Inc. | 2013-10-28 | Traditional | PDF ↗ |
| K123696 | MEDUSA VASCULAR PLUG | Endoshape, Inc. | 2013-10-25 | Traditional | PDF ↗ |
| K132675 | EMBOZENE MICROSPHERES | Celonova Biosciences, Inc. | 2013-10-03 | Special | PDF ↗ |
| K132578 | INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corp | 2013-09-13 | Special | PDF ↗ |
| K123803 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | Reverse Medical Corporation | 2013-07-02 | Traditional | PDF ↗ |
| K130577 | AZUR PUSHABLE 18 & 35 SYSTEM | MicroVention, Inc. | 2013-06-17 | Special | PDF ↗ |
| K130307 | ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE | Celonova Biosciences, Inc. | 2013-03-04 | Special | PDF ↗ |
| K123712 | RETRACTA DETACHABLE EMBOLIZATION COIL | Cook Incorporated | 2013-01-03 | Special | PDF ↗ |
| K123384 | AZUR CX DETACHABLE 18 | MicroVention, Inc. | 2012-11-28 | Special | PDF ↗ |
| K122543 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | MicroVention, Inc. | 2012-11-28 | Traditional | PDF ↗ |
| K122316 | AZUR DETACHABLE 35 | MicroVention, Inc. | 2012-08-29 | Special | PDF ↗ |
| K113658 | AMPLATZER VASCULAR PLUG 4 | Aga Medical Corp. | 2012-06-12 | Traditional | PDF ↗ |
| K113266 | GEL-BLOCK EMBOLIZATION PLEDGETS | Vascular Solutions, Inc. | 2012-05-14 | Traditional | PDF ↗ |
| K120816 | INZONE DETACHMENT SYSTEM | Stryker | 2012-04-17 | Special | PDF ↗ |
| K120630 | AZUR DETACHABLE 18 | MicroVention, Inc. | 2012-03-28 | Special | PDF ↗ |
| K113651 | INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corporation | 2012-01-11 | Special | PDF ↗ |
| K112103 | INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corp | 2011-08-12 | Special | PDF ↗ |
| K111307 | AZUR DETACHABLE 35 PLATINUM COIL SYSTEM | MicroVention, Inc. | 2011-06-15 | Traditional | PDF ↗ |
| K110295 | INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corp | 2011-03-03 | Special | PDF ↗ |
| K102912 | INTERLOCK FIBERED IDC OCCLUSION SYSTEM | Boston Scientific | 2011-03-03 | Traditional | PDF ↗ |
| K102714 | COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL | Boston Scientific Corp | 2011-02-11 | Traditional | PDF ↗ |
| K102365 | MICROPLEX COIL SYSTEM- COSMOS | MicroVention, Inc. | 2010-11-18 | Traditional | PDF ↗ |
| K091952 | ACTA VESSEL OCCLUSION SYSTEM (VOS) | Nfocus Neuromedical, Inc. | 2010-09-10 | Abbreviated | PDF ↗ |
Product code KRD · Class II · Cardiovascular. Data: openFDA.