FDA Product Code
FDA Product Code DQK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1425
510(k) Clearances — 439 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | Centerline Biomedical | 2026-10-01 | Special | PDF ↗ |
| K261729 | EnSite X EP System | Abbott Medical | 2026-09-17 | Traditional | PDF ↗ |
| K253692 | AVVIGO+ Multi-Modality Guidance System | Boston Scientific | 2026-08-21 | Traditional | PDF ↗ |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026-08-21 | Special | PDF ↗ |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 | Traditional | PDF ↗ |
| K262006 | EnSite X EP System | Abbott Medical | 2026-07-15 | Special | PDF ↗ |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 | Traditional | PDF ↗ |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 | Traditional | PDF ↗ |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 | Special | PDF ↗ |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 | Traditional | PDF ↗ |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | 2026-06-10 | Special | PDF ↗ |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 | Traditional | PDF ↗ |
| K260212 | EnSite X EP System | ABBOTT MEDICAL | 2026-04-20 | Traditional | PDF ↗ |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 | Traditional | PDF ↗ |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 | Traditional | PDF ↗ |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 | Traditional | PDF ↗ |
| K252972 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 | Traditional | PDF ↗ |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical, Inc. | 2026-02-17 | Traditional | PDF ↗ |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 | Traditional | PDF ↗ |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K252164 | NorthStar Mapping System | Imricor Medical Systems | 2026-01-28 | Traditional | PDF ↗ |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026-01-18 | Special | PDF ↗ |
| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | 2025-12-19 | Special | PDF ↗ |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 | Traditional | PDF ↗ |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 | Traditional | PDF ↗ |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 | Traditional | PDF ↗ |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025-10-24 | Traditional | PDF ↗ |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2025-10-24 | Abbreviated | PDF ↗ |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025-10-21 | Special | PDF ↗ |
| K252013 | EnSite X EP System | ABBOTT MEDICAL | 2025-09-25 | Traditional | PDF ↗ |
| K251518 | Volta AF-Xplorer II | Volta Medical | 2025-09-12 | Traditional | PDF ↗ |
| K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | ABBOTT MEDICAL | 2025-09-04 | Special | PDF ↗ |
| K252302 | CARTO 3 EP Navigation System V8.1 | Biosense Webster, Inc. | 2025-08-22 | Special | PDF ↗ |
| K251234 | EnSite X EP System | ABBOTT MEDICAL | 2025-07-30 | Traditional | PDF ↗ |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | Edwards Lifesciences | 2025-07-23 | Traditional | PDF ↗ |
| K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025-06-25 | Traditional | PDF ↗ |
| K250749 | PhysCade System | Physcade, Inc. | 2025-06-04 | Traditional | PDF ↗ |
| K251344 | OptiMap System | Boston Scientific Corporation | 2025-05-28 | Special | PDF ↗ |
| K250932 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-05-27 | Traditional | PDF ↗ |
| K243812 | Volta AF-Xplorer | Volta Medical | 2025-05-09 | Traditional | PDF ↗ |
| K242129 | VitalRhythm | Vitalconnect, Inc. | 2025-04-17 | Traditional | PDF ↗ |
| K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025-03-06 | Traditional | PDF ↗ |
| K243312 | CER-S | Cardiocalm Srl | 2025-02-20 | Traditional | PDF ↗ |
| K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025-01-17 | Special | PDF ↗ |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | Ge Medical Systems Information Technologies, Inc. | 2024-12-12 | Special | PDF ↗ |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024-12-05 | Special | PDF ↗ |
| K241197 | DeepRhythmAI | Medicalgorithmics S.A. | 2024-12-04 | Traditional | PDF ↗ |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | 2024-11-01 | Traditional | PDF ↗ |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | Centerline Biomedical, Inc. | 2024-10-11 | Special | PDF ↗ |
| K241227 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | 2024-08-29 | Traditional | PDF ↗ |
| K233755 | HeartKey® Rhythm | B-Secur Limited | 2024-08-16 | Traditional | PDF ↗ |
| K242016 | EnSite X EP System | ABBOTT MEDICAL | 2024-08-09 | Special | PDF ↗ |
| K240509 | STAR Apollo Mapping System | Rhythm AI, Ltd. | 2024-07-26 | Traditional | PDF ↗ |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | Centerline Biomedical, Inc. | 2024-07-24 | Special | PDF ↗ |
| K233326 | Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated | 2024-06-21 | Traditional | PDF ↗ |
| K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2024-03-14 | Special | PDF ↗ |
| K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) | Medtronic, Inc. | 2024-03-08 | Traditional | PDF ↗ |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | Ge Medical Systems Information Technologies, Inc. | 2023-12-13 | Traditional | PDF ↗ |
| K233160 | NeuTrace EP Mapping System v.2.1 | Anumana, Inc. | 2023-11-25 | Traditional | PDF ↗ |
| K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One) | Edwards Lifesciences, LLC | 2023-10-31 | Traditional | PDF ↗ |
| K232616 | Volta AF-Xplorer | Volta Medical | 2023-09-27 | Special | PDF ↗ |
| K230884 | AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation | 2023-09-26 | Traditional | PDF ↗ |
| K223812 | Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. | 2023-09-15 | Traditional | PDF ↗ |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | 2023-09-07 | Traditional | PDF ↗ |
| K230579 | Smart Wedge algorithm | Edwards Lifesciences, LLC | 2023-08-18 | Traditional | PDF ↗ |
| K231415 | EnSite X EP System | ABBOTT MEDICAL | 2023-08-10 | Traditional | PDF ↗ |
| K223787 | ECGenius System | Cath Vision Aps | 2023-08-04 | Traditional | PDF ↗ |
| K231620 | Nuubo Smart | Smart Solutions Technologies SL | 2023-08-01 | Traditional | PDF ↗ |
| K231035 | FusedCO Algorithm | Edwards Lifesciences, LLC | 2023-07-12 | Traditional | PDF ↗ |
| K231091 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023-07-10 | Traditional | PDF ↗ |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | Centerline Biomedical, Inc. | 2023-06-21 | Special | PDF ↗ |
| K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | Edwards Lifesciences, LLC | 2023-06-09 | Traditional | PDF ↗ |
| K230008 | Ablamap® System | Ablacon, Inc. | 2023-06-08 | Traditional | PDF ↗ |
| K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | Philips Medical Systems Nederland B.V. | 2023-06-08 | Abbreviated | PDF ↗ |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023-05-02 | Traditional | PDF ↗ |
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4 | Biosense Webster, Inc. | 2023-02-16 | Traditional | PDF ↗ |
| K222389 | ZEUS System | iRhythm Technologies, Inc. | 2023-02-15 | Traditional | PDF ↗ |
| K223516 | VX1+ | Volta Medical | 2023-01-21 | Traditional | PDF ↗ |
| K211557 | EndoPATx | Itamar Medical , Ltd. | 2022-12-29 | Traditional | PDF ↗ |
| K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License | ABBOTT MEDICAL | 2022-12-27 | Traditional | PDF ↗ |
| K220786 | STAR Apollo Mapping System | Rhythm Al, Ltd. | 2022-12-01 | Traditional | PDF ↗ |
| K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) | Edwards Lifesciences, LLC | 2022-11-22 | Traditional | PDF ↗ |
| K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022-11-07 | Special | PDF ↗ |
| K212493 | KODEX EPD System 1.5.0 | Philips Medical Systems Nederland, B.V. (Pmsn) | 2022-10-24 | Traditional | PDF ↗ |
| K222209 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022-10-17 | Traditional | PDF ↗ |
| K221213 | EnSite X EP System | Abbott | 2022-08-18 | Traditional | PDF ↗ |
| K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | Biosense Webster, Inc. | 2022-08-17 | Traditional | PDF ↗ |
| K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022-07-27 | Traditional | PDF ↗ |
| K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | 2022-07-19 | Traditional | PDF ↗ |
| K220784 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022-07-01 | Traditional | PDF ↗ |
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote | Edwards Lifesciences, LLC | 2022-06-22 | Traditional | PDF ↗ |
| K220306 | ECGenius System | Cath Vision Aps | 2022-05-03 | Traditional | PDF ↗ |
| K220243 | Ultiri Measurement System | ABBOTT MEDICAL | 2022-04-30 | Traditional | PDF ↗ |
| K212662 | AliveCor QT Service | AliveCor, Inc. | 2022-04-26 | Traditional | PDF ↗ |
| K213861 | CER-S | Cardiocalm Srl | 2022-04-25 | Traditional | PDF ↗ |
| K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX | Ge Healthcare Information Technologies, Inc. | 2022-02-17 | Traditional | PDF ↗ |
| K202094 | Cardiovascular Suite 4.2.1 | Quipu S.R.L | 2022-01-11 | Traditional | PDF ↗ |
| K213364 | EnSite X EP System | ABBOTT MEDICAL | 2021-11-11 | Special | PDF ↗ |
| K211546 | Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. | 2021-11-09 | Traditional | PDF ↗ |
| K210543 | IM007 | Implicity, Inc. | 2021-11-03 | Traditional | PDF ↗ |
Product code DQK · Class II · Cardiovascular. Data: openFDA.