Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 48
- Latest Decision
- 2023-04-20
Clearances · page 14 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | DWP | Class II | 2023-04-20 |
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface | Medtronic, Inc. | QWF | Class II | 2023-04-19 |
| K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | DWA | Class II | 2023-04-18 |
| K221895 | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DTQ | Class II | 2023-04-18 |
| K230494 | ClotTriever BOLD Catheter | Inari Medical, Inc. | QEW | Class II | 2023-04-18 |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device | Rapid Medical Ltd. | NRY | Class II | 2023-04-17 |
| K213676 | Masimo Rad-G with Temperature | Masimo Corporation | DQA | Class II | 2023-04-16 |
| K230411 | Dragonfly OpStar Imaging Catheter | ABBOTT MEDICAL | DQO | Class II | 2023-04-14 |
| K223785 | N9+ | Nonagon , Ltd. | DQD | Class II | 2023-04-14 |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | DTR | Class II | 2023-04-13 |
| K222185 | Stratus Infusion Catheter | Intervene, Inc. | NPG | Class II | 2023-04-13 |
| K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | DXN | Class II | 2023-04-12 |
| K230705 | POT PTCA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | LOX | Class II | 2023-04-11 |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | NRY | Class II | 2023-04-11 |
| K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | NTE | Class II | 2023-04-11 |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister | Argon Medical Devices, Inc. | KRA | Class II | 2023-04-10 |
| K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | Famidoc Technology Company Limited | DXN | Class II | 2023-04-10 |
| K230695 | APRO 70 Catheter and Alembic Aspiration Tubing | Alembic, LLC | NRY | Class II | 2023-04-10 |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | Corcym S.r.l. | KRH | Class II | 2023-04-07 |
| K222023 | RayFlow | Hexacath | DQY | Class II | 2023-04-06 |
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | GE Healthcare Finland Oy | MHX | Class II | 2023-04-06 |
| K230640 | Affinity Fusion Oxygenator System | Medtronic, Inc. | DTZ | Class II | 2023-04-06 |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | MXD | Class II | 2023-04-05 |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | LIT | Class II | 2023-04-05 |
| K213584 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | QLZ | Class II | 2023-04-04 |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly | Cardinal Health200, LLC | JOW | Class II | 2023-04-03 |
| K222370 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | DSA | Class II | 2023-04-02 |
| K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | QEW | Class II | 2023-03-31 |
| K230356 | Aspirex Thrombectomy System | C.R. Bard, Inc. | QEW | Class II | 2023-03-31 |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | KRA | Class II | 2023-03-30 |
| K222871 | Stethophone v1 | Sparrow Acoustics, Inc. | DQD | Class II | 2023-03-29 |
| K221805 | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | DQD | Class II | 2023-03-23 |
| K223419 | Triever16 Curve | Inari Medical | QEW | Class II | 2023-03-23 |
| K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor | Boston Scientific Corporation | DRA | Class II | 2023-03-22 |
| K230191 | Arise UHP Dilatation Catheter | Creagh Medical, Ltd. | LIT | Class II | 2023-03-22 |
| K223049 | CardioSTAT® ECG Test Solution | Icentia, Inc. | DSH | Class II | 2023-03-22 |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte. , Ltd. | DRS | Class II | 2023-03-17 |
| K223613 | InThrill Thrombectomy System | Inari Medical, Inc. | QEW | Class II | 2023-03-17 |
| K223073 | Alio | Alio, Inc. | DRG | Class II | 2023-03-17 |
| K223666 | Ablacath Mapping Catheter | Ablacon, Inc. | MTD | Class II | 2023-03-17 |
| K212906 | HeartBuds Electronic Stethoscope | Heartbuds, LLC | DQD | Class II | 2023-03-14 |
| K230145 | ONE-CUF | Ge Medical Systems Information Technologies, Inc. | DXQ | Class II | 2023-03-14 |
| K223609 | RevCore Thrombectomy Catheter. | Inari Medical, Inc. | QEW | Class II | 2023-03-14 |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, LLC | MOF | Class II | 2023-03-10 |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | 2023-03-09 |
| K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | DQY | Class II | 2023-03-09 |
| K221930 | CEREGLIDE 71 Intermediate Catheter | Cerenovus, Inc. | QJP | Class II | 2023-03-09 |
| K221373 | Essenz HLM | Livanova Deutschland, GmbH | DTQ | Class II | 2023-03-09 |
| K221700 | AutoPulse NXT Resuscitation System | Zoll Circulation, Inc. | DRM | Class II | 2023-03-09 |
| K223432 | Vassallo GT 018 Hybrid | Filmecc Co., Ltd. | DQX | Class II | 2023-03-09 |
| K220101 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2023-03-08 |
| K230331 | Protrieve Sheath | Inari Medical, Inc. | QEW | Class II | 2023-03-07 |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | MWI | Class II | 2023-03-06 |
| K222394 | Electronic Sphygmomanometers | Qingdao Yasee Medical Device Co., Ltd. | DXN | Class II | 2023-03-03 |
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | DWM | Class II | 2023-03-03 |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Compression Works, Inc. | DXC | Class II | 2023-03-03 |
| K223436 | Artix AX | Inari Medical | QEW | Class II | 2023-03-02 |
| K230253 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | MTD | Class II | 2023-03-02 |
| K222603 | 6F Wallaby Long Sheath | Wallaby Medical, Inc. | DQY | Class II | 2023-03-02 |
| K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) | ABBOTT MEDICAL | DYB | Class II | 2023-03-01 |
| K213898 | ProTrack Pigtail Wire | Baylis Medical Company, Inc. | DQX | Class II | 2023-03-01 |
| K230248 | VIOLA | Vascular Graft Solutions, Ltd. | DXC | Class II | 2023-02-28 |
| K213431 | Handheld Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | DQA | Class II | 2023-02-26 |
| K223216 | Symphony Thrombectomy System | Truvic Medical, Inc. | QEW | Class II | 2023-02-23 |
| K223161 | OXY-1 System | Abiomed, Inc. | DTZ | Class II | 2023-02-23 |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | MSX | Class II | 2023-02-23 |
| K222184 | Introducer Sheath Kits | Beijing Demax Medical Technology Co.,Ltd | DYB | Class II | 2023-02-21 |
| K223545 | APRO 70 Catheter and Alembic Aspiration Tubing | Alembic, LLC | NRY | Class II | 2023-02-17 |
| K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc. | QEW | Class II | 2023-02-17 |
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4 | Biosense Webster, Inc. | DQK | Class II | 2023-02-16 |
| K223766 | NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. | OBJ | Class II | 2023-02-16 |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | LIT | Class II | 2023-02-16 |
| K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | LOX | Class II | 2023-02-15 |
| K222869 | Arm Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2023-02-15 |
| K222389 | ZEUS System | iRhythm Technologies, Inc. | DQK | Class II | 2023-02-15 |
| K223891 | Cobra Catheter System | Endovascular Engineering | QEW | Class II | 2023-02-15 |
| K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | QEW | Class II | 2023-02-13 |
| K222398 | Care Team Portal | Vivify Health, Inc. | DRG | Class II | 2023-02-06 |
| K221531 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | 2023-02-06 |
| K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | DWA | Class II | 2023-02-03 |
| K230051 | 14F iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | 2023-02-03 |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | Microlife Intellectual Property GmbH | DXN | Class II | 2023-02-03 |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific, Inc. | OWQ | Class II | 2023-02-03 |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Böblingen GmbH | MHX | Class II | 2023-02-03 |
| K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | MOF | Class II | 2023-01-26 |
| K223516 | VX1+ | Volta Medical | DQK | Class II | 2023-01-21 |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | LIT | Class II | 2023-01-20 |
| K222158 | Capiflo 5001 | K&L Distributing, Inc. | JOW | Class II | 2023-01-20 |
| K223166 | Medaica M1 Telehealth Stethoscope | Medaica, Inc. | DQD | Class II | 2023-01-19 |
| K223872 | Low Profile Companion Sheath | Merit Medical Systems, Inc. | DYB | Class II | 2023-01-19 |
| K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | PDU | Class II | 2023-01-19 |
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console | Zoll Circulation, Inc. | NCX | Class II | 2023-01-13 |
| K221774 | Garmin ECG App | Garmin International, Inc. | QDA | Class II | 2023-01-12 |
| K223000 | Artix BG | Inari Medical | QEW | Class II | 2023-01-11 |
| K222115 | ISAAC Neurovascular Navigation Catheter | MicroVention, Inc. | DQY | Class II | 2023-01-10 |
| K213423 | T3 Platform software | Etiometry, Inc. | PLB | Class II | 2023-01-06 |
| K221260 | CSF-3 | Cardiacsense | DPS | Class II | 2023-01-06 |
| K222182 | Radial Artery Compression Tourniquets | Beijing Demax Medical Technology Co.,Ltd | DXC | Class II | 2023-01-04 |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Shanghai Microport EP Medtech Co., Ltd. | DRF | Class II | 2022-12-30 |
| K213430 | Fingertip Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | DQA | Class II | 2022-12-30 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.