Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 48
- Latest Decision
- 2018-04-27
Clearances · page 31 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K172258 | Novasight Hybrid System | Conavi Medical, Inc. | OBJ | Class II | 2018-04-27 |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | DQK | Class II | 2018-04-23 |
| K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | DRG | Class II | 2018-04-23 |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | MTD | Class II | 2018-04-23 |
| K172167 | Zenith Flex System | Inneuroco, Inc. | NRY | Class II | 2018-04-19 |
| K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical, Ltd. | LIT | Class II | 2018-04-19 |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | 2018-04-19 |
| K173661 | Wingman 35 Crossing Catheter | Reflow Medical, Inc. | DQY | Class II | 2018-04-18 |
| K180081 | RAILWAY Sheathless Access System | Cordis Corporation | DYB | Class II | 2018-04-18 |
| K172880 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2018-04-18 |
| K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System | Cardiovascular Systems, Inc. | MCW | Class II | 2018-04-17 |
| K180723 | PreludeSYNC DISTAL Radial Compression System | Merit Medical Systems, Inc. | DXC | Class II | 2018-04-17 |
| K173226 | CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. | DPS | Class II | 2018-04-16 |
| K180126 | SOZO | ImpediMed Limited | OBH | Class II | 2018-04-16 |
| K172315 | Straub Endovascular System | Straub Medical AG | MCW | Class II | 2018-04-12 |
| K173515 | Admiral Xtreme | Medtronic Vascular | LIT | Class II | 2018-04-12 |
| K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire | Boston Scientific | DQX | Class II | 2018-04-12 |
| K172187 | Inno-Hydrowire | Suzhou Innomed Medical Device Co., Ltd. | DQX | Class II | 2018-04-11 |
| K171379 | Digital Automatic Wrist Blood Pressure Monitor MD4300 | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2018-04-10 |
| K180329 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | 2018-04-09 |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | MCW | Class II | 2018-04-05 |
| K172014 | Wedge Microcatheter | MicroVention, Inc. | DQY | Class II | 2018-04-05 |
| K173586 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | KRA | Class II | 2018-04-05 |
| K180088 | TrapLiner catheter | Vascular Solutions, Inc. | DQY | Class II | 2018-04-04 |
| K172141 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | DQA | Class II | 2018-04-04 |
| K180566 | Unite Connect for Clinical Systems | Ascom Sweden AB | MSX | Class II | 2018-04-03 |
| K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | DQO | Class II | 2018-04-03 |
| K172635 | High-Flo Silver Polyethylene Catheter | Cook Incorporated | DQO | Class II | 2018-04-03 |
| K171988 | Performer Guiding Sheath | Cook Incorporated | DYB | Class II | 2018-03-30 |
| K171997 | Mandril Wire Guide | Cook Incorporated | DQX | Class II | 2018-03-30 |
| K173548 | Merit Pursue Microcatheter | Merit Medical Systems, Inc. | DQY | Class II | 2018-03-30 |
| K172071 | 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 | 2018-03-29 |
| K173439 | Bloom2 Programmable Electrophysiology Stimulator | Fischer Medical | JOQ | Class II | 2018-03-29 |
| K173799 | NaviCross 0.018 | Terumo Corporation | DQY | Class II | 2018-03-29 |
| K180517 | CorPath GRX System | Corindus, Inc. | DXX | Class II | 2018-03-29 |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical , Ltd. | DRY | Class II | 2018-03-28 |
| K180558 | PressureWire X | St. Jude Medical (Now Part of Abbott Medical) | DXO | Class II | 2018-03-28 |
| K171241 | Pulse Oximeter | Hunan Accurate Bio-Medical Technology Co., Ltd. | DQA | Class II | 2018-03-27 |
| K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | 2018-03-27 |
| K173886 | CPRmeter 2 CPR Feedback Device | Laerdal Medical AS | LIX | Class II | 2018-03-23 |
| K180456 | Bio-Medicus Adult Cannulae Kit | Medtronic, Inc. | DWF | Class II | 2018-03-22 |
| K180453 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | DWF | Class II | 2018-03-22 |
| K180023 | WIRION | Gardia Medical , Ltd. | NTE | Class II | 2018-03-21 |
| K171912 | Double Flexible Tip Wire Guides | Cook Incorporated | DQX | Class II | 2018-03-19 |
| K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | LOX | Class II | 2018-03-19 |
| K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm | Stryker | NRY | Class II | 2018-03-18 |
| K172366 | Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2018-03-16 |
| K180411 | MEMO 4D | Sorin Group Italia S.R.L. | KRH | Class II | 2018-03-16 |
| K171937 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2018-03-16 |
| DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences, LLC | QAQ | Class II | 2018-03-16 |
| K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter | Sorin Group Italia S.R.L. | DTZ | Class II | 2018-03-15 |
| K173203 | Athena GTX Device Management Suite (ADMS) Software | Athena Gtx | MSX | Class II | 2018-03-14 |
| K172431 | Cardiovascular Analzyer | Physiowave, Inc. | DSB | Class II | 2018-03-14 |
| K171764 | Fixed Core Wire Guides | Cook Incorporated | DQX | Class II | 2018-03-09 |
| K171820 | Transjugular Liver Access Sets | Cook Incorporated | DYB | Class II | 2018-03-09 |
| K162616 | Wrist Type Blood Pressure Monitor | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | DXN | Class II | 2018-03-09 |
| K172892 | Neuro Assessment System NAS-1000 | Headsense Medical, Inc. | QBE | Class II | 2018-03-08 |
| K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister | Penumbra, Inc. | QEW | Class II | 2018-03-08 |
| K180335 | Accutension Smartphone Auscultatory Blood | Shanghai Hulu Devices Co., Ltd. | DXQ | Class II | 2018-03-08 |
| K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | OWQ | Class II | 2018-03-06 |
| K172331 | Type I, Type II, Type III, Type IV | Lepu Medical Technology (Beijing) Co., Ltd. | DYB | Class II | 2018-03-02 |
| K172103 | Flowtron DVT5 Small Calf Garment | Getinge (Suzhou) Co., Ltd. | JOW | Class II | 2018-03-02 |
| K172972 | Wrist Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology CO ., Ltd. | DXN | Class II | 2018-03-02 |
| K173806 | CorPath GRX System | Corindus, Inc. | DXX | Class II | 2018-03-01 |
| K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | LOX | Class II | 2018-03-01 |
| K172797 | ECG Cable/Leadwires | Shenzhen Coreray Technology, Ltd. | DSA | Class II | 2018-02-28 |
| K180244 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | PLA | Class II | 2018-02-28 |
| K180242 | HeRO Symphony, HeRO ES, HeRO solo/duet | Medical Predictive Science Corporation | DPS | Class II | 2018-02-28 |
| K171668 | Bluetooth blood pressure monitor | Visiomed Group SA | DXN | Class II | 2018-02-26 |
| K173381 | Nexxis OR | Barco N.V. | DXJ | Class II | 2018-02-22 |
| K173236 | Sentry IVC Filter | Novate Medical , Ltd. | DTK | Class II | 2018-02-22 |
| K172950 | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | DRC | Class II | 2018-02-21 |
| K171620 | PiCCO Catheter | Pulsion Medical Systems SE | KRB | Class II | 2018-02-21 |
| K170866 | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 | Honsun (Nantong) Co., Ltd. | DXN | Class II | 2018-02-21 |
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | Edwards Lifescience, LLC | DQE | Class II | 2018-02-20 |
| K171646 | ACISTCVi® Contrast Delivery System | Acist Medical Systems, Inc. | DXT | Class II | 2018-02-16 |
| K172934 | Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC | DRC | Class II | 2018-02-16 |
| K180128 | Warrior 14 guidewire | Vascular Solutions, Inc. | DQX | Class II | 2018-02-16 |
| K173750 | Prelude IDeal Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | 2018-02-15 |
| K173288 | CorPath GRX System | Corindus, Inc. | DXX | Class II | 2018-02-15 |
| K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter | Asahi Intecc Co., Ltd. | DQX | Class II | 2018-02-12 |
| K173894 | Jade PTA Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | LIT | Class II | 2018-02-09 |
| K173553 | LUCAS 3 Chest Compression System | Jolife AB | DRM | Class II | 2018-02-08 |
| K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | DXT | Class II | 2018-02-07 |
| K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | DYB | Class II | 2018-02-06 |
| K173528 | Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System | Devon Medical Products (Jiangsu), Ltd. | JOW | Class II | 2018-02-06 |
| K171361 | BETTERCARE PLATFORM - ADVANCED WEB CLIENT | Better Care S.L. | MWI | Class II | 2018-02-05 |
| K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter | Inari Medical | QEW | Class II | 2018-02-05 |
| K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | MJN | Class II | 2018-01-31 |
| K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | DQO | Class II | 2018-01-26 |
| K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | DXJ | Class II | 2018-01-26 |
| K172716 | V2K Rinspiration System | V2k Medical, Inc. | QEW | Class II | 2018-01-26 |
| K172896 | Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 | Shenzhen Jiacom Technology CO ., Ltd. | DXN | Class II | 2018-01-26 |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | Inneuroco, Inc. | DQY | Class II | 2018-01-26 |
| K162665 | MiCor A100 Wearable ECG Recorder | Mitac International Corp. | DPS | Class II | 2018-01-26 |
| K173581 | Gallant PTCA Dilatation Catheter | Medinol, Ltd. | LOX | Class II | 2018-01-25 |
| K173448 | CliniCloud Stethoscope | Stethocloud Pty.Ltd (Clinicloud) | DQD | Class II | 2018-01-25 |
| K171264 | Royal Flush Catheter | Cook Incorporated | DQO | Class II | 2018-01-25 |
| K171942 | Electrocardiograph | Edan Instruments, Inc. | DPS | Class II | 2018-01-24 |
| K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile | Scientia Vascular, LLC | DQX | Class II | 2018-01-22 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.