Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 46
- Latest Decision
- 2018-08-08
Clearances · page 30 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters | Cordis, A Cardinal Health Company | DQO | Class II | 2018-08-08 |
| K180248 | VascuEase IC-1200-WH | Bio Compression Systems, Inc. | JOW | Class II | 2018-08-07 |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile | Scientia Vascular, LLC | MOF | Class II | 2018-08-07 |
| K181217 | VesoFlow Lite DVT Compression Device | Caremed Supply, Inc. | JOW | Class II | 2018-08-05 |
| K181323 | Atlas Gold PTA Dilatation Catheter | C.R. Bard, Inc. | LIT | Class II | 2018-08-03 |
| K180155 | Arm Type Blood Pressure Monitor | Avita Corporation | DXN | Class II | 2018-08-03 |
| K181237 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Corporation | DYB | Class II | 2018-08-03 |
| K173461 | ECG recorder and Arrhythmia Detector | Smart Solutions Technologies SL | DSH | Class II | 2018-08-03 |
| K173923 | Temporary Cardiac Pacing Wire | ETHICON, Inc. | LDF | Class II | 2018-08-02 |
| K173869 | Med-link Reusable Blood Pressure Cuff | Shenzhen Med-Link Electronics Tech Co., Ltd. | DXQ | Class II | 2018-08-02 |
| K181720 | Epiphany Cardio Server Mobile | Epiphany Healthcare, LLC | DQK | Class II | 2018-07-30 |
| K172616 | Pulse Oximeter | Beijing Safe Heart Technology , Ltd. | DQA | Class II | 2018-07-27 |
| K181694 | FlowTriever Retrieval/Aspiration System | Inari Medical | QEW | Class II | 2018-07-27 |
| K181699 | Level 1 Convective Warmer | Smiths Medical Asd, Inc. | DWJ | Class II | 2018-07-26 |
| K181855 | RadialSeal Introducer Kit | Great Batch Medical | DYB | Class II | 2018-07-26 |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Shockwave Medical, Inc. | PPN | Class II | 2018-07-26 |
| K173107 | Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. | DXJ | Class II | 2018-07-26 |
| K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0) | Boston Scientific Corporation | DQK | Class II | 2018-07-25 |
| K173929 | CipherOx CRI M1 | Flashback Technologies, Inc. | PPW | Class II | 2018-07-24 |
| K172862 | Portable ECG Monitor (ECG3) | Andon Health Co, Ltd. | DSH | Class II | 2018-07-24 |
| K180017 | MX40 Release C.01 | Philips Medical Systems | MHX | Class II | 2018-07-24 |
| K181647 | Bandit guidewire | Vascular Solutions, Inc. | DQX | Class II | 2018-07-20 |
| K180864 | WATCHMAN TruSeal Access System | Boston Scientific | DQY | Class II | 2018-07-20 |
| K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | MUD | Class II | 2018-07-19 |
| K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters | AngioDynamics, Inc. | DQO | Class II | 2018-07-18 |
| K180784 | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES | Asahi Intecc Co., Ltd. | DQX | Class II | 2018-07-18 |
| K180151 | MC3 Jugular Dual Lumen Catheter | Mc3 Incorporated | PZS | Class II | 2018-07-16 |
| K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | 2018-07-16 |
| K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | DXJ | Class II | 2018-07-16 |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | DSI | Class II | 2018-07-11 |
| K172694 | Sterile Disposable Syringes | Shenyang Mastech Medical Device Co., Ltd. | DXT | Class II | 2018-07-06 |
| K173277 | ASAHI PTCA Guide Wire ASAHI SION black | Asahi Intecc Co., Ltd. | DQX | Class II | 2018-07-05 |
| K172778 | CheckMyHeart Plus | Dailycare Biomedical, Inc. | DPS | Class II | 2018-07-05 |
| K180705 | Riptide Aspiration System React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | 2018-07-04 |
| K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY | Class II | 2018-07-04 |
| K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | JOW | Class II | 2018-06-29 |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | LOX | Class II | 2018-06-28 |
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | DPW | Class II | 2018-06-28 |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | PPN | Class II | 2018-06-27 |
| 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 | DTZ | Class II | 2018-06-22 |
| DEN170004 | Ellipsys Vascular Access System | Avenu Medical, Inc. | PQK | Class II | 2018-06-22 |
| K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm | Shape Memory Medical | KRD | Class II | 2018-06-22 |
| DEN160006 | everlinQ endoAVF System | Tva Medical, Inc. | PQK | Class II | 2018-06-22 |
| K172586 | Vios Monitoring System Model 2050 | Vios Medical, Inc. | DRT | Class II | 2018-06-22 |
| K172779 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | JOW | Class II | 2018-06-22 |
| K180785 | iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | 2018-06-22 |
| K172770 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | JOW | Class II | 2018-06-22 |
| K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Healthstats International Pte. , Ltd. | DXN | Class II | 2018-06-21 |
| K180008 | Penumbra System | Penumbra, Inc. | NRY | Class II | 2018-06-20 |
| K180472 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | MHX | Class II | 2018-06-19 |
| K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | Innovative Health, LLC | NLH | Class II | 2018-06-19 |
| K172895 | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 | Ageless Health Industrial Co., Ltd. | DXN | Class II | 2018-06-18 |
| K180726 | Savion DLVR Guidewire, Savion FLX Guidewire | Boston Scientific, Inc. | DQX | Class II | 2018-06-18 |
| K181325 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | 2018-06-17 |
| K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) | Hmicro, Inc. | DRG | Class II | 2018-06-14 |
| K181351 | Double Flexible Tipped Wire Guides | Cook Incorporated | DQX | Class II | 2018-06-14 |
| K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | Biosense Webster, Inc. | DQK | Class II | 2018-06-14 |
| K180722 | CAPERE Thrombectomy System | Kp Medcure, Inc. | QEW | Class II | 2018-06-11 |
| K173200 | SOFIA Plus Aspiration Catheter | MicroVention, Inc. | NRY | Class II | 2018-06-11 |
| K180959 | Phenom 27 Catheter | Cathera, Inc. | DQY | Class II | 2018-06-11 |
| K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | MWJ | Class II | 2018-06-08 |
| K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | MJN | Class II | 2018-06-08 |
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | APK Technology Co., Ltd. | DQA | Class II | 2018-06-08 |
| K181202 | Sentry IVC Filter | Novate Medical , Ltd. | DTK | Class II | 2018-06-06 |
| K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 | Taidoc Technology Corporation | MWI | Class II | 2018-06-06 |
| K173045 | Oximeter | Shenzhen Greatmade Tech Limited | DQA | Class II | 2018-06-05 |
| K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | Cook Incorporated | DYB | Class II | 2018-06-04 |
| K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | DQK | Class II | 2018-06-01 |
| K172068 | Kenz Cardico1211 | Suzuken Co., Ltd. | DPS | Class II | 2018-06-01 |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | DSP | Class II | 2018-05-31 |
| K171019 | ScioCardio ECG Transmitter | Synergen Technology Labs, LLC | DRG | Class II | 2018-05-30 |
| K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | DRN | Class II | 2018-05-30 |
| K173246 | ANEROID SPHYGMOMANOMETER | Wenzhou Bokang Instruments Co., Ltd. | DXQ | Class II | 2018-05-30 |
| K180174 | Belun Ring | Belun Technology Company Limited | DQA | Class II | 2018-05-29 |
| K181132 | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic | KRH | Class II | 2018-05-29 |
| K173834 | Quantum Pump Console | Spectrum Medical , Ltd. | DTQ | Class II | 2018-05-25 |
| K181150 | ProtekDuo Mini Veno-Venous Cannula Set | Cardiacassist, Inc. | DWF | Class II | 2018-05-25 |
| K172147 | STAR 65 | Skanray Technologies Pvt, Ltd. | MWI | Class II | 2018-05-25 |
| K180201 | Route 92 Medical Access System | Route 92 Medical, Inc. | DQY | Class II | 2018-05-23 |
| K173862 | Pantheris System | Avinger, Inc. | MCW | Class II | 2018-05-22 |
| K180375 | The IQoolTM Warm System | Braincool AB | DWJ | Class II | 2018-05-18 |
| K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | DXK | Class II | 2018-05-17 |
| K180742 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | PLA | Class II | 2018-05-17 |
| K181023 | Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter | Meril Life Sciences Private Limited | LOX | Class II | 2018-05-17 |
| K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | 2018-05-17 |
| K180986 | XableCath Support Catheter Product Family | Xablecath, Inc. | DQY | Class II | 2018-05-15 |
| K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | Penumbra, Inc. | QEW | Class II | 2018-05-15 |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | Nonin Medical, Inc. | DQA | Class II | 2018-05-11 |
| K172510 | µCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | MHX | Class II | 2018-05-11 |
| K173012 | ANGIO-PRESS LITE DVT Compression Device | Pegasus Medical Supply, Inc. | JOW | Class II | 2018-05-10 |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | MUD | Class II | 2018-05-10 |
| K173452 | EmboTrap ll Revascularization Device | Neuravi, Ltd. | NRY | Class II | 2018-05-09 |
| K180913 | VSI Micro-Introducer Kit | Vascular Solutions, Inc. | DYB | Class II | 2018-05-09 |
| K173510 | BioStamp nPoint | Mc10, Inc. | DRG | Class II | 2018-05-08 |
| K173831 | Glidesheath Slender | Terumo Medical Corporation | DYB | Class II | 2018-05-08 |
| K180157 | QT ECG | QT Medical, Inc. | DXH | Class II | 2018-05-04 |
| K172980 | Micropuncture Pedal Access Set | Cook Incorporated | DYB | Class II | 2018-05-03 |
| K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | DQX | Class II | 2018-05-03 |
| K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | QEW | Class II | 2018-05-03 |
| K172959 | PeraServer and PeraTrend | Perahealth, Inc. | MWI | Class II | 2018-05-01 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.