Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 46
- Latest Decision
- 2019-03-13
Clearances · page 28 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm | Stryker | DQY | Class II | 2019-03-13 |
| K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | Stryker | NRY | Class II | 2019-03-13 |
| K183469 | Microlife Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2019-03-12 |
| K181823 | KardiaAI | AliveCor, Inc. | DQK | Class II | 2019-03-11 |
| K182553 | Inno-Pathwire | Suzhou Innomed Medical Device Co., Ltd. | DQX | Class II | 2019-03-11 |
| K190184 | iSLEEVE Introducer Set | Boston Scientific | DYB | Class II | 2019-03-07 |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | DRT | Class II | 2019-03-07 |
| K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | DYB | Class II | 2019-03-07 |
| K182344 | RhythmAnalytics | Biofourmis Singapore Pte., Ltd. | DQK | Class II | 2019-03-07 |
| K183078 | VitalConnect Platform, VitalPatch Biosensor | Vitalconnect, Inc. | DRG | Class II | 2019-03-07 |
| K182495 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | DXN | Class II | 2019-03-03 |
| K183266 | EP-TRACER System | Schwarzer Cardiotek GmbH | DQK | Class II | 2019-03-01 |
| DEN180021 | Early Bird Bleed Monitoring System | Saranas, Inc. | QFJ | Class II | 2019-03-01 |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | 2019-03-01 |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | 2019-03-01 |
| K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | DQK | Class II | 2019-02-28 |
| K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | DTE | Class II | 2019-02-28 |
| K180479 | ReDS System | Sensible Medical Innovations , Ltd. | DSB | Class II | 2019-02-28 |
| K182003 | Lympha Press Optimal Plus | Mego Afek AC , Ltd. | JOW | Class II | 2019-02-27 |
| K182494 | FlowMet-R | Laser Associated Sciences, Inc. | DPW | Class II | 2019-02-27 |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | Thrombolex, Inc. | QEY | Class II | 2019-02-25 |
| K183179 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | 2019-02-25 |
| K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | Innovative Health, LLC | NLH | Class II | 2019-02-22 |
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | Cardiocomm Solutions, Inc. | DXH | Class II | 2019-02-22 |
| K182578 | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device | Devon Medical Products (Jiangsu), Ltd. | JOW | Class II | 2019-02-21 |
| K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | DXH | Class II | 2019-02-16 |
| K183556 | oCare Wrist Pulse Oximeter | Taiwan Biophotonic Corporation | DQA | Class II | 2019-02-15 |
| K181353 | Lunderquist® Fixed Core Wire Guide | Cook Incorporated | DQX | Class II | 2019-02-15 |
| K181930 | GMC Wrist Automatic Blood Pressure Monitor | Gmc, Inc. | DXN | Class II | 2019-02-14 |
| K183635 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | PSQ | Class II | 2019-02-14 |
| K182934 | FORA P100 Blood Pressure Monitoring System | Taidoc Technology Corporation | DXN | Class II | 2019-02-12 |
| K190078 | IntraSight | Volcano Corporation | DSA | Class II | 2019-02-11 |
| K182040 | Coala Heart Monitor | Coala Life AB | DXH | Class II | 2019-02-08 |
| K181577 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2019-02-07 |
| K182796 | WavelinQ 4F EndoAVF System | C.R. Bard, Inc. | PQK | Class II | 2019-02-06 |
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | Orantech, Inc. | DSA | Class II | 2019-01-30 |
| K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 | Asahi Intecc Co., Ltd. | MOF | Class II | 2019-01-29 |
| K182093 | ZOLL ECG Analysis Software | Zoll Manufacturing Corporation | DPS | Class II | 2019-01-28 |
| K183631 | medi pneumatic compression system (pcs) brio (Model 651) | Medi USA, LP | JOW | Class II | 2019-01-25 |
| K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | Avenu Medical, Inc. | PQK | Class II | 2019-01-25 |
| K182297 | Surveyor S2 | Mortara Instrument, Inc. | DRG | Class II | 2019-01-24 |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | Stryker Sustainability Solutions | NLH | Class II | 2019-01-24 |
| K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | DQA | Class II | 2019-01-23 |
| K183357 | XableCath Crossing Catheter | Xablecath, Inc. | PDU | Class II | 2019-01-21 |
| K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | Innovative Health, LLC | OWQ | Class II | 2019-01-18 |
| K182456 | Study Watch | Verily Life Sciences, LLC | DXH | Class II | 2019-01-17 |
| K183467 | Roadrunner Extra Support Wire Guide | Cook Incorporated | DQX | Class II | 2019-01-11 |
| K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | Covidien, LLC | MUD | Class II | 2019-01-08 |
| K180435 | Arm Blood Pressure Monitor | Alicn Medical (Shenzhen), Inc. | DXN | Class II | 2019-01-03 |
| K183000 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | DQY | Class II | 2018-12-29 |
| K183369 | COR12 ECG | Corscience GmbH & Co. | DPS | Class II | 2018-12-28 |
| K182242 | VO200 NeurOs Cerebral Oximetry System | Mespere Lifesciences, Inc. | QEM | Class II | 2018-12-26 |
| K180380 | vital signs monitor | Edan Instruments, Inc. | DQA | Class II | 2018-12-21 |
| K173036 | North-vision Multi-parameter Patient Monitor | North-Vision Tech., Inc. | MHX | Class II | 2018-12-21 |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | NormaTec Industries, LP | JOW | Class II | 2018-12-21 |
| K182167 | The ICHOR Panacea Vascular Embolectomy Catheter System | Ichor Vascular, Inc. | QEW | Class II | 2018-12-21 |
| K183036 | Dilator Sets | Cook Incorporated | DRE | Class II | 2018-12-20 |
| K180830 | Reuter Tip Deflecting Wire Guide | Cook Incorporated | DQX | Class II | 2018-12-20 |
| K183267 | DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | DXT | Class II | 2018-12-20 |
| K182972 | Phoenix Atherectomy System | Volcano Atheromed, Inc. | MCW | Class II | 2018-12-20 |
| K182420 | ASAHI Corsair Pro XS | Asahi Intecc Co., Ltd. | DQY | Class II | 2018-12-20 |
| K182149 | FFRangio System | Cathworks, Ltd. | QEK | Class II | 2018-12-19 |
| K180846 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | DQO | Class II | 2018-12-19 |
| K182150 | Devon 52 Sequential Compression Device | Devon Medical Products (Jiangsu), Ltd. | JOW | Class II | 2018-12-18 |
| K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration System) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | 2018-12-18 |
| K183348 | Reusable Silicone Cover CPRmeter 2 | Laerdal Medical AS | LIX | Class II | 2018-12-17 |
| K181877 | Phoenix 2.4mm Atherectomy Plus System | Volcano Atheromed, Inc. | MCW | Class II | 2018-12-17 |
| K181612 | Tyto Stethoscope (OTC) | Tyto Care , Ltd. | DQD | Class II | 2018-12-17 |
| K172965 | Handheld VitalSigns Monitoring System | Visiomed Technology Co.,Ltd | MWI | Class II | 2018-12-17 |
| K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | QEW | Class II | 2018-12-17 |
| K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | DXQ | Class II | 2018-12-17 |
| K181269 | iCertainty | Rfpi | DPW | Class II | 2018-12-14 |
| K182905 | UniPulse | Seaward Group | DRL | Class II | 2018-12-14 |
| K180797 | Xcess Guiding Catheter | Curatia Medical Co. | DQY | Class II | 2018-12-14 |
| K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. | DPS | Class II | 2018-12-14 |
| K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | MWI | Class II | 2018-12-14 |
| K181463 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | DYB | Class II | 2018-12-13 |
| K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | DQY | Class II | 2018-12-13 |
| K181372 | Argos | Retia Medical, LLC | DXG | Class II | 2018-12-13 |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascular Systems, Inc. | MCW | Class II | 2018-12-13 |
| K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | DQK | Class II | 2018-12-12 |
| K182512 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | DQY | Class II | 2018-12-10 |
| K182075 | BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2018-12-10 |
| K180889 | Tractus Crossing Support Catheter | Tractus Vascular, LLC | DQY | Class II | 2018-12-07 |
| K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection | Contego Medical, LLC | LIT | Class II | 2018-12-06 |
| K182035 | FFRct | HeartFlow, Inc. | PJA | Class II | 2018-12-06 |
| K183116 | Unity Network ID | GE Healthcare | MWI | Class II | 2018-12-06 |
| K180792 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | DQO | Class II | 2018-11-30 |
| K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System | Edwards Lifesciences, LLC | DXN | Class II | 2018-11-30 |
| K173589 | Prizma | G-Medical Innovations , Ltd. | DXH | Class II | 2018-11-30 |
| K180482 | ZOLL Propaq M | ZOLL Medical Corporation | MHX | Class II | 2018-11-30 |
| K180685 | AS-3XX Series Fingertip Pulse Oximeter | Xiamen Acurio Instruments Co., Ltd. | DQA | Class II | 2018-11-29 |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | DRA | Class II | 2018-11-26 |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LOX | Class II | 2018-11-26 |
| K182324 | EkoSonic Endovascular System | Btg International, Inc. | QEY | Class II | 2018-11-26 |
| K180430 | Digistat Smart Central | Ascom Ums Srl Unipersonale | MSX | Class II | 2018-11-23 |
| K182967 | Visor System | Cerebrotech Medical Systems, Inc. | QAF | Class II | 2018-11-23 |
| K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | OTD | Class II | 2018-11-21 |
| K180432 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd. | DQK | Class II | 2018-11-19 |
| K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | DQK | Class II | 2018-11-16 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.