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 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021-10-29 | Special | PDF ↗ |
| K212061 | EnSite X EP System | Abbott | 2021-10-22 | Traditional | PDF ↗ |
| K212490 | AVVIGO Guidance System II | Boston Scientific Corporation | 2021-10-20 | Special | PDF ↗ |
| K203084 | Ablamap Software | Ablacon, Inc. | 2021-08-31 | Traditional | PDF ↗ |
| K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021-08-27 | Special | PDF ↗ |
| K201094 | iMap 3D Mapping & Navigation System (iMap System) | Cardionxt, Inc. | 2021-08-16 | Traditional | PDF ↗ |
| K210680 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021-08-05 | Traditional | PDF ↗ |
| K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021-07-08 | Traditional | PDF ↗ |
| K210889 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2021-06-25 | Special | PDF ↗ |
| K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index | Edwards Lifesciences, LLC | 2021-05-28 | Traditional | PDF ↗ |
| K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | 2021-05-21 | Traditional | PDF ↗ |
| K201921 | Spacelabs Lifescreen PRO Analyzer | Spacelabs Healthcare, Ltd. | 2021-03-26 | Traditional | PDF ↗ |
| K210392 | WorkMate Claris System | Abbott | 2021-03-11 | Special | PDF ↗ |
| K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | Philips Medical System Nederland B.V. | 2020-12-17 | Traditional | PDF ↗ |
| K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020-12-08 | Traditional | PDF ↗ |
| K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020-12-01 | Traditional | PDF ↗ |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | ABBOTT MEDICAL | 2020-11-25 | Traditional | PDF ↗ |
| K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020-11-25 | Traditional | PDF ↗ |
| K201060 | Cordiana Dx16 | Cordiana Medical Informatics AG | 2020-11-16 | Traditional | PDF ↗ |
| K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | 2020-11-13 | Traditional | PDF ↗ |
| K201985 | KardiaAI | AliveCor, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020-10-01 | Traditional | PDF ↗ |
| K201298 | VX1 | Volta Medical | 2020-09-16 | Traditional | PDF ↗ |
| K200313 | VIVO | Catheter Precision, Inc. | 2020-09-14 | Traditional | PDF ↗ |
| K201713 | AVVIGO Guidance System | Boston Scientific Corporation | 2020-07-23 | Special | PDF ↗ |
| K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License | ABBOTT MEDICAL | 2020-06-26 | Traditional | PDF ↗ |
| K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | ABBOTT MEDICAL | 2020-06-26 | Traditional | PDF ↗ |
| K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific | 2020-05-29 | Special | PDF ↗ |
| K193013 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020-02-11 | Traditional | PDF ↗ |
| K192438 | Rhythmia HDxTM Mapping System | Boston Scientific Corporation | 2019-11-27 | Traditional | PDF ↗ |
| K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019-09-06 | Traditional | PDF ↗ |
| K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019-08-29 | Traditional | PDF ↗ |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2019-08-23 | Traditional | PDF ↗ |
| K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019-07-20 | Special | PDF ↗ |
| K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2019-07-02 | Traditional | PDF ↗ |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | Centerline Biomedical, Inc. | 2019-06-24 | Traditional | PDF ↗ |
| K183195 | VIVO | Catheter Precision, Inc. | 2019-06-14 | Traditional | PDF ↗ |
| K191089 | Edwards Pressure Cable | Edwards Lifesciences, LLC | 2019-06-13 | Traditional | PDF ↗ |
| K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019-04-02 | Traditional | PDF ↗ |
| K181823 | KardiaAI | AliveCor, Inc. | 2019-03-11 | Traditional | PDF ↗ |
| K182344 | RhythmAnalytics | Biofourmis Singapore Pte., Ltd. | 2019-03-07 | Traditional | PDF ↗ |
| K183266 | EP-TRACER System | Schwarzer Cardiotek GmbH | 2019-03-01 | Special | PDF ↗ |
| K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | 2019-02-28 | Traditional | PDF ↗ |
| K181577 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019-02-07 | Traditional | PDF ↗ |
| K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | 2018-12-12 | Special | PDF ↗ |
| K180432 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd. | 2018-11-19 | Traditional | PDF ↗ |
| K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018-11-16 | Traditional | PDF ↗ |
| K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | 2018-11-08 | Traditional | PDF ↗ |
| K180940 | KODEX EPD System | Philips Medical Systems Nederland B.V. | 2018-10-24 | Traditional | PDF ↗ |
| K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | 2018-10-19 | Special | PDF ↗ |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018-08-29 | Traditional | PDF ↗ |
| K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | Biosense Webster, Inc. | 2018-08-24 | Traditional | PDF ↗ |
| K180805 | Pure EP | Biosig Technologies | 2018-08-08 | Traditional | PDF ↗ |
| K181720 | Epiphany Cardio Server Mobile | Epiphany Healthcare, LLC | 2018-07-30 | Traditional | PDF ↗ |
| K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0) | Boston Scientific Corporation | 2018-07-25 | Traditional | PDF ↗ |
| K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | Biosense Webster, Inc. | 2018-06-14 | Traditional | PDF ↗ |
| K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018-06-01 | Traditional | PDF ↗ |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018-04-23 | Traditional | PDF ↗ |
| K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2017-10-16 | Traditional | PDF ↗ |
| K171583 | RhythmView Workstation | Abbott Electrophysiology | 2017-09-01 | Traditional | PDF ↗ |
| K172182 | QUANTIEN Measurement System | St. Jude Medical (Now Part of the Abbott Medical) | 2017-08-18 | Special | PDF ↗ |
| K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017-07-25 | Traditional | PDF ↗ |
| K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | Edwards Lifesciences, LLC | 2017-04-14 | Traditional | PDF ↗ |
| K162023 | CardioDay V2.5 | Getemed Medizin- Und Informationstechnik AG | 2017-03-24 | Traditional | PDF ↗ |
| K162793 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | 2017-03-10 | Traditional | PDF ↗ |
| K160210 | EnSite Precision Cardiac Mapping System v2.0 | St Jude Medical | 2016-12-13 | Traditional | PDF ↗ |
| K162643 | MediGuide Technology System | St Jude Medical | 2016-12-13 | Traditional | PDF ↗ |
| K160218 | AutoMark Module | St Jude Medical | 2016-12-13 | Traditional | PDF ↗ |
| K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016-11-04 | Special | PDF ↗ |
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | St Jude Medical | 2016-10-21 | Traditional | PDF ↗ |
| K160186 | EnSite Velocity Surface Electrode Kit | St Jude Medical | 2016-10-07 | Traditional | PDF ↗ |
| K153654 | Sentry WEB SmartInterp | Carefusion Germany 234 GmbH | 2016-09-16 | Traditional | PDF ↗ |
| K161465 | CardioConfirm | Mortara Instrument, Inc. | 2016-09-03 | Traditional | PDF ↗ |
| K161240 | Rhythm View Workstation (non-streaming) | Abbott Electrophysiology | 2016-08-10 | Traditional | PDF ↗ |
| K161245 | EP-TRACER System | Cardio Tek, BV | 2016-08-05 | Traditional | PDF ↗ |
| K152864 | Merge Hemo | Merge Healthcare Incorporated | 2016-04-07 | Traditional | PDF ↗ |
| K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM | Spacelabs Healthcare, Ltd. | 2016-04-01 | Traditional | PDF ↗ |
| K152160 | Navik 3D | Apn Health, LLC | 2016-02-23 | Traditional | PDF ↗ |
| K151787 | Holter System | Edan Instruments, Inc. | 2016-01-27 | Traditional | PDF ↗ |
| K152993 | MUSE Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2016-01-12 | Special | PDF ↗ |
| K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015-10-22 | Traditional | PDF ↗ |
| K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015-10-06 | Traditional | PDF ↗ |
| K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015-09-21 | Traditional | PDF ↗ |
| K151245 | Rhythm View Workstation (non-streaming, steaming option) | Topera, Inc. | 2015-09-15 | Traditional | PDF ↗ |
| K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015-07-02 | Special | PDF ↗ |
| K150493 | Sensis | Siemens Medi Cal Solutions, Inc. | 2015-06-30 | Traditional | PDF ↗ |
| K143449 | ADH 200 Analyzer Software | Adams Meditech, LLC | 2015-06-26 | Traditional | PDF ↗ |
| K142901 | RhythmView Workstation | Topera, Inc. | 2014-12-19 | Special | PDF ↗ |
| K142681 | ZEUS (ZIO ECG Utilization Service) System | iRhythm Technologies, Inc. | 2014-11-21 | Special | PDF ↗ |
| K140497 | ECVUE MAPPING SYSTEM | Cardioinsight Technologies, Inc. | 2014-11-19 | Traditional | PDF ↗ |
| K133916 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 | Biosense Webster, Inc. | 2014-07-01 | Traditional | PDF ↗ |
| K141050 | ENSITE VELOCITY SYSTEM | St Jude Medical | 2014-06-06 | Traditional | PDF ↗ |
| K141185 | V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM | Boston Scientific Corp | 2014-06-06 | Special | PDF ↗ |
| K133534 | MCKESSON CARDIOLOGY ECG MOBILE | Mckesson Israel , Ltd. | 2014-04-18 | Traditional | PDF ↗ |
| K134044 | EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM | Cardio Tek, BV | 2014-03-31 | Traditional | PDF ↗ |
| K132782 | CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 | Biosense Webster, Inc. | 2014-01-24 | Traditional | PDF ↗ |
| K133305 | RHYTHM VIEW WORKSTATION | Topera, Inc. | 2013-12-16 | Special | PDF ↗ |
| K132437 | MARS HOLTER ANALYSIS WORKSTATION | Ge Medical Systems Information Technologies, Inc. | 2013-12-04 | Special | PDF ↗ |
| K132073 | EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE | St Jude Medical | 2013-09-09 | Special | PDF ↗ |
| K130727 | ENSITE VELOCITY SYSTEM | St Jude Medical | 2013-08-29 | Traditional | PDF ↗ |
Product code DQK · Class II · Cardiovascular. Data: openFDA.