Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 46
- Latest Decision
- 2022-09-14
Clearances · page 16 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213854 | SavvyWire | Opsens, Inc. | DQX | Class II | 2022-09-14 |
| K221843 | GEM Biover Microvascular Clamps | Synovis Micro Companies Alliance, Inc. | DXC | Class II | 2022-09-14 |
| K214024 | SOFIA 88 Catheter | MicroVention, Inc. | DQY | Class II | 2022-09-12 |
| K220567 | Easi-Vue embolic microspheres System | Abk Biomedical, Inc. | KRD | Class II | 2022-09-07 |
| K213868 | ASAHI Gladius Mongo18 PV ES | Asahi Intecc Co., Ltd. | DQX | Class II | 2022-09-06 |
| K220962 | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | MCW | Class II | 2022-09-06 |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. | LIT | Class II | 2022-09-02 |
| K221040 | Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) | Jiangxi Aicare Medical Technology Co., Ltd. | DXN | Class II | 2022-08-31 |
| K221541 | LimFlow ARC | LimFlow, Inc. | PDU | Class II | 2022-08-31 |
| K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | DRB | Class II | 2022-08-30 |
| K221486 | INDEX BPM | Ya Horng Electronic Co., Ltd. | DXN | Class II | 2022-08-30 |
| K220676 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2022-08-29 |
| K221212 | Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. | DXN | Class II | 2022-08-26 |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | MXD | Class II | 2022-08-25 |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | DRE | Class II | 2022-08-24 |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences, LLC | DXF | Class II | 2022-08-22 |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp | LIT | Class II | 2022-08-22 |
| K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons , Ltd. | DQX | Class II | 2022-08-19 |
| K221213 | EnSite X EP System | Abbott | DQK | Class II | 2022-08-18 |
| K213390 | Benchmark BMX96 Access System | Penumbra, Inc. | QJP | Class II | 2022-08-18 |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | Vascular Solutions, LLC | DQY | Class II | 2022-08-18 |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS | Qura S.R.L | DWF | Class II | 2022-08-18 |
| K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | Biosense Webster, Inc. | DQK | Class II | 2022-08-17 |
| K212385 | YUWELL Finger Pulse Oximeter | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DQA | Class II | 2022-08-16 |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | 2022-08-16 |
| K213845 | HeRO Graft | Merit Medical Systems, Inc. | DSY | Class II | 2022-08-15 |
| K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | MHX | Class II | 2022-08-11 |
| K221879 | Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 | Caf Medical Solutions, Inc. | MHX | Class II | 2022-08-10 |
| K222083 | LimFlow V-Ceiver | LimFlow, Inc. | MMX | Class II | 2022-08-09 |
| K221854 | Reprocesses Umbilical Cable | Innovative Health, LLC | NLH | Class II | 2022-08-06 |
| K221628 | exGraft, exGraft Carbon | Peca Labs | DSY | Class II | 2022-08-04 |
| K221953 | Masimo CARESCAPE SpO2 Masimo with SpHb | Masimo Corporation | DQA | Class II | 2022-08-04 |
| K220887 | Mini-ClotTriever Thrombectomy System | Inari Medical | QEW | Class II | 2022-08-04 |
| K210179 | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | DSH | Class II | 2022-08-02 |
| K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | MHX | Class II | 2022-08-01 |
| K221914 | Catapult Guide Sheath | Contract Medical International, GmbH | DYB | Class II | 2022-07-29 |
| K220989 | Next Generation NetKonnect | Nihon Kohden Digital Health Solutions, Inc. | MHX | Class II | 2022-07-29 |
| K220331 | 091 Balloon Guide Catheter | Inneuroco, Inc. | DQY | Class II | 2022-07-29 |
| K211585 | Bodyport Cardiac Scale | Bodyport, Inc. | DSB | Class II | 2022-07-29 |
| K222017 | Biotres | Biotricity | MWJ | Class II | 2022-07-28 |
| K210822 | DeepRhythmAI | Medicalgorithmics S.A. | DQK | Class II | 2022-07-27 |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | MXD | Class II | 2022-07-27 |
| K221464 | CorPath GRX System | Corindus, Inc. | DXX | Class II | 2022-07-27 |
| K220886 | Upper Arm Type Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | DXN | Class II | 2022-07-27 |
| K220808 | Tigertriever 13 Revascularization Device | Rapid Medical Ltd. | NRY | Class II | 2022-07-25 |
| K212975 | MedWand | Medwand Solutions, Inc. | MWI | Class II | 2022-07-22 |
| K222037 | Selectra Lead Implantation System | Biotronik, Inc. | DQY | Class II | 2022-07-19 |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | KRA | Class II | 2022-07-19 |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | DXH | Class II | 2022-07-19 |
| K212215 | Tiche PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | LIT | Class II | 2022-07-19 |
| K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | DQK | Class II | 2022-07-19 |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | DRG | Class II | 2022-07-15 |
| K221203 | AHI System | Fifth Eye, Inc. | QNV | Class II | 2022-07-14 |
| K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2022-07-12 |
| K220415 | Protrieve Sheath | Inari Medical, Inc. | QEW | Class II | 2022-07-12 |
| K221846 | Artix Ballon Guiding Sheath | Inari Medical | DQY | Class II | 2022-07-11 |
| K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Medi USA, LP | JOW | Class II | 2022-07-07 |
| K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | LIT | Class II | 2022-07-06 |
| K213385 | GEM | Obsidio, Inc. | KRD | Class II | 2022-07-01 |
| K213315 | CROSSLEAD Peripheral Guide Wire | Asahi Intecc Co., Ltd. | DQX | Class II | 2022-07-01 |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Northeast Scientific, Inc. | QTF | Class II | 2022-07-01 |
| K220784 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2022-07-01 |
| K213949 | VASSALLO GT 018 Floppy | Filmecc Co., Ltd. | DQX | Class II | 2022-06-30 |
| K221750 | CPS AIM Universal II Slittable Inner Catheter | ABBOTT MEDICAL | DQY | Class II | 2022-06-30 |
| K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | LOX | Class II | 2022-06-30 |
| K213582 | Epicardial Access System | Baylis Medical Company, Inc. | DYB | Class II | 2022-06-30 |
| K220651 | Wrist Type Blood Pressure Monitor | Shenzhen Jamr Medical Technology Co., Ltd. | DXN | Class II | 2022-06-30 |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | LIT | Class II | 2022-06-29 |
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | DQD | Class II | 2022-06-29 |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) | Ra Medical Systems,Inc | PDU | Class II | 2022-06-29 |
| K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | MOF | Class II | 2022-06-29 |
| K213577 | VenAir, Sequential Compression System | Apex Medical Corp. | JOW | Class II | 2022-06-28 |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Shenzhen Med-Link Electronics Tech Co., Ltd. | DSA | Class II | 2022-06-28 |
| K221204 | Excipio SV Thrombectomy Device | Contego Medical, Inc. | QEW | Class II | 2022-06-23 |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | DRG | Class II | 2022-06-23 |
| K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) | Huizhou Xiaoou Technology Co., Ltd. | DQA | Class II | 2022-06-22 |
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote | Edwards Lifesciences, LLC | DQK | Class II | 2022-06-22 |
| K213230 | T3 Platform Software | Etiometry, Inc. | PPW | Class II | 2022-06-22 |
| K220270 | Aspirex Thrombectomy System | C.R. Bard, Inc. | QEW | Class II | 2022-06-21 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | MTD | Class II | 2022-06-21 |
| K213255 | CipherOx CRI Tablet | Flashback Technologies, Inc. | PPW | Class II | 2022-06-17 |
| K221470 | Langston dual lumen catheter | Vascular Solutions, LLC | DQO | Class II | 2022-06-17 |
| K220106 | QardioArm 2 | Qardio, Inc. | DXN | Class II | 2022-06-15 |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | 2022-06-12 |
| K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | KRA | Class II | 2022-06-10 |
| K213515 | WesperO2 | Wesper, Inc. | DQA | Class II | 2022-06-10 |
| K220796 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | DRF | Class II | 2022-06-10 |
| K221077 | Auryon Atherectomy System | Eximo Medical, Ltd. | MCW | Class II | 2022-06-09 |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | LIT | Class II | 2022-06-09 |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | MSX | Class II | 2022-06-07 |
| K211046 | eCareManager 4.5 | Visicu, Inc. | MSX | Class II | 2022-06-03 |
| K213971 | Atrial Fibrillation History Feature | Apple, Inc. | QDB | Class II | 2022-06-03 |
| K220761 | CIRCUL8 Connect DVT Prevention Device | Ortho8, Inc. | JOW | Class II | 2022-06-03 |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console | Zoll Circulation, Inc. | NCX | Class II | 2022-06-02 |
| K220632 | Boss Crossing Support Catheter | Marvao Medical Devices, Ltd. | DQY | Class II | 2022-06-02 |
| K210758 | Q Patch | Medicalgorithmics S.A. | MWJ | Class II | 2022-06-02 |
| K212288 | Minjie Catheter System | Kai Medtech, LLC | QJP | Class II | 2022-06-02 |
| K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MSX | Class II | 2022-06-01 |
| K220766 | eMurmur Heart AI | Csd Labs GmbH | DQD | Class II | 2022-05-31 |
| K221440 | Liverty TIPS Access Set | Bard Peripheral Vascular, Inc. | DYB | Class II | 2022-05-31 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.