Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 49
- Latest Decision
- 2019-12-20
Clearances · page 25 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190008 | Carescape One | GE Healthcare | MHX | Class II | 2019-12-20 |
| K192833 | Indigo Aspiration System | Penumbra, Inc. | QEW | Class II | 2019-12-20 |
| K190939 | ZOLL Arrhythmia Management Sysyem | Zoll Manufacturing Corporation | MHX | Class II | 2019-12-19 |
| K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | KRA | Class II | 2019-12-19 |
| K192313 | Halo One Thin-Walled Guiding Sheath | C.R. Bard, Inc. | DYB | Class II | 2019-12-19 |
| K191614 | BioSticker System | Biointellisense, Inc. | DRG | Class II | 2019-12-18 |
| K191667 | Electronic Stethoscope | Hefei Mintti Medical Technology Co., Ltd. China | DQD | Class II | 2019-12-18 |
| K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | DXG | Class II | 2019-12-17 |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | MMX | Class II | 2019-12-17 |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | QEY | Class II | 2019-12-17 |
| K192267 | ILUMIEN System with AptiVue Software version D.3 | ABBOTT MEDICAL | DQO | Class II | 2019-12-17 |
| K192762 | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | KRH | Class II | 2019-12-16 |
| K190833 | AXS Vecta Aspiration Catheter | Stryker Neurovascular | DQY | Class II | 2019-12-15 |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | Bayer Medical Care, Inc. | DXT | Class II | 2019-12-13 |
| K193194 | CrossTorq 14 Guidewire | Scientia Cardio Access, LLC | DQX | Class II | 2019-12-13 |
| K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | MHX | Class II | 2019-12-13 |
| K191163 | Lumax Guiding Catheter | Cook Incorporated | DQY | Class II | 2019-12-12 |
| K192340 | OptoMonitor | Opsens, Inc. | DXO | Class II | 2019-12-12 |
| K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | Innovative Health, LLC | DRF | Class II | 2019-12-11 |
| K193126 | HI-TORQUE InfilTrac Guide Wire Family | Abbott Vascular | DQX | Class II | 2019-12-11 |
| K192439 | JETi Peripheral Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | 2019-12-09 |
| K192442 | FFRangio | Cathworks, Ltd. | QEK | Class II | 2019-12-09 |
| K190273 | T3 Platform software | Etiometry, Inc. | MWI | Class II | 2019-12-08 |
| K191279 | Disposable SpO2 Sensor | Shenzhen Caremed Medical Technology Co., Ltd. | DQA | Class II | 2019-12-06 |
| K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | DXT | Class II | 2019-12-05 |
| K193068 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | JOW | Class II | 2019-12-04 |
| K193020 | VenaPro Vascular Therapy System | Innovamed Health, LLC | JOW | Class II | 2019-12-04 |
| K193069 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | JOW | Class II | 2019-12-04 |
| K193160 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Coporation | DYB | Class II | 2019-12-03 |
| K193107 | TriSalus Infusion System | Trisalus Life Sciences | KRA | Class II | 2019-12-03 |
| K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | DQA | Class II | 2019-12-02 |
| K193034 | AXS Infinity LS Plus Long Sheath | Stryker Neurovascular | DQY | Class II | 2019-11-29 |
| K192782 | ASAHI CROSSWALK Peripheral Support Catheter | Asahi Intecc Co., Ltd. | DQY | Class II | 2019-11-29 |
| K192438 | Rhythmia HDxTM Mapping System | Boston Scientific Corporation | DQK | Class II | 2019-11-27 |
| K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | DXG | Class II | 2019-11-27 |
| K191673 | Upper Arm Blood Pressure Monitor | Famidoc Technology Company Limited | DXN | Class II | 2019-11-27 |
| K191428 | ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | DSA | Class II | 2019-11-27 |
| K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | LIT | Class II | 2019-11-26 |
| K191502 | Heraeus Peripheral Guidewire | Heraeus Medical Components, LLC | DQX | Class II | 2019-11-26 |
| K190529 | SOZO | ImpediMed Limited | QJB | Class II | 2019-11-25 |
| K192122 | Trevo Trak 21 Microcatheter | Stryker | DQO | Class II | 2019-11-22 |
| K191734 | MatriStem UBM Pericardial Patch | Acell, Inc. | PSQ | Class II | 2019-11-22 |
| K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | DQY | Class II | 2019-11-21 |
| K192625 | PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company | DQY | Class II | 2019-11-21 |
| K192480 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | KRD | Class II | 2019-11-21 |
| K191464 | Asahi PTCA Guide Wire Asahi SION Series | Asahi Intecc Co., Ltd. | DQX | Class II | 2019-11-21 |
| K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2019-11-19 |
| K192769 | Impella CP Introducer | Abiomed, Inc. | DYB | Class II | 2019-11-18 |
| K192935 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | 2019-11-15 |
| K190478 | Reprocessed ViewFlex Xtra ICE Catheter | Sterilmed, Inc. | OWQ | Class II | 2019-11-14 |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex | DSP | Class II | 2019-11-12 |
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 | ABBOTT MEDICAL | DQO | Class II | 2019-11-08 |
| K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | DQY | Class II | 2019-11-08 |
| K190334 | MIMOSA Imager | Mimosa Diagnostics, Inc. | MUD | Class II | 2019-11-01 |
| K192525 | 087 Balloon Guide Catheter System | Q'Apel Medical, LLC | DQY | Class II | 2019-10-31 |
| K191769 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2019-10-31 |
| K192083 | Okami Medical LOBO Vascular Occlusion System | Okami Medical | KRD | Class II | 2019-10-30 |
| K190267 | EZE SIT Valvulotome | Lemaitre Vascular | MGZ | Class II | 2019-10-30 |
| K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile | Scientia Vascular, LLC | DQX | Class II | 2019-10-30 |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | Stereotaxis, Inc. | PJB | Class II | 2019-10-30 |
| K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter | Innovative Health, LLC | NLH | Class II | 2019-10-30 |
| K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | DSJ | Class II | 2019-10-27 |
| K192360 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | DRF | Class II | 2019-10-25 |
| K190221 | IOB Warming Blankets | Iob Medical, Inc. | DWJ | Class II | 2019-10-25 |
| K190037 | Cronus HP PTA Balloon Catheter | Nipro Medical Corporation | LIT | Class II | 2019-10-24 |
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | MUD | Class II | 2019-10-21 |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | QEY | Class II | 2019-10-18 |
| K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott | MXC | Class II | 2019-10-18 |
| K191430 | Pulse Oximeter | Shenzhen Yimi Life-Technology Co., Ltd. | DQA | Class II | 2019-10-18 |
| K192556 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | 2019-10-17 |
| K192239 | WavelinQ Plus EndoAVF System | C.R. Bard, Inc. | PQK | Class II | 2019-10-17 |
| K190102 | DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System | Osprey Medical, Inc. | DXT | Class II | 2019-10-17 |
| K191420 | Reusable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | DQA | Class II | 2019-10-11 |
| K191417 | Belun Ring | Belun Technology Company Limited | DQA | Class II | 2019-10-10 |
| K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire | Phenox Limited | DQX | Class II | 2019-10-09 |
| K192422 | Steerable Introducer 12F | Freudenberg Medical, LLC | DRA | Class II | 2019-10-04 |
| K183710 | Vivio System | Avicena, LLC | DQD | Class II | 2019-10-04 |
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | Bard Peripheral Vascular, Inc. | LIT | Class II | 2019-10-03 |
| K191444 | Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir | Medtronic, Inc. | DTZ | Class II | 2019-09-27 |
| K192195 | Sterile Dilator | Galt Medical Corp. | DRE | Class II | 2019-09-26 |
| K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | MWI | Class II | 2019-09-25 |
| K190574 | Patient Assistant Model PA97000 | Medtronic, Inc. | DSI | Class II | 2019-09-24 |
| K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | MUD | Class II | 2019-09-23 |
| K192296 | Medtronic 6F Taiga Guiding Catheter | Medtronic Vascular | DQY | Class II | 2019-09-20 |
| K192332 | ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath | Inari Medical | QEW | Class II | 2019-09-20 |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | Orbusneich Medical Trading, Inc. | LOX | Class II | 2019-09-19 |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL | DRF | Class II | 2019-09-17 |
| K191253 | Reusable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | DXQ | Class II | 2019-09-17 |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | MUD | Class II | 2019-09-16 |
| K190507 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2019-09-16 |
| K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | OBI | Class II | 2019-09-13 |
| K191273 | Multi-Link X2 ECG and SpO2 Adapter | Vyaire Medical, Inc. | DSA | Class II | 2019-09-13 |
| K190869 | Pulse Oximeter | Shenzhen Aeon Technology Co., Ltd. | DQA | Class II | 2019-09-13 |
| K191419 | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire | Rex Medical, L.P. | MCW | Class II | 2019-09-12 |
| K183370 | PeraMobile and PeraWatch | Perahealth, Inc. | MWI | Class II | 2019-09-11 |
| K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | DXN | Class II | 2019-09-11 |
| K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | DRN | Class II | 2019-09-10 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare , Ltd. | DPW | Class II | 2019-09-06 |
| K183027 | Steerable catheter control system | Stereotaxis, Inc. | PJB | Class II | 2019-09-06 |
| K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2019-09-06 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.