Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 53
- Latest Decision
- 2021-07-06
Clearances · page 20 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K203459 | SafeCross Transseptal Puncture and Introducer (TSP/I) System | East End Medical I, LLC | DYB | Class II | 2021-07-06 |
| K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LOX | Class II | 2021-07-02 |
| K211411 | Penumbra System (RED 68 Reperfusion Catheter) | Penumbra, Inc. | NRY | Class II | 2021-07-01 |
| K203057 | Quantum Perfusion Arterial Cannula Graft | Qura S.R.L | DWF | Class II | 2021-06-30 |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | Philips Medical Systems | DPS | Class II | 2021-06-30 |
| K210753 | KardiaMobile 6L | AliveCor, Inc. | DXH | Class II | 2021-06-30 |
| K210889 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | DQK | Class II | 2021-06-25 |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | MTD | Class II | 2021-06-23 |
| K211044 | Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | LIT | Class II | 2021-06-16 |
| K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | Volcano Atheromed, Inc. | MCW | Class II | 2021-06-14 |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | MXD | Class II | 2021-06-11 |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) | Thrombolex, Inc. | QEY | Class II | 2021-06-10 |
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care, Inc. | NRY | Class II | 2021-06-08 |
| K201914 | HRVWatch-Mini Wrist Monitor | Taiwan Scientific Corporation | DXN | Class II | 2021-06-07 |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | AngioDynamics, Inc. | QEZ | Class II | 2021-06-04 |
| K200722 | PCA-C1 series Patient Cable | QT Medical, Inc. | DSA | Class II | 2021-06-03 |
| K210627 | Breezeway II | Oscor, Inc. | DYB | Class II | 2021-06-03 |
| K211304 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | MXD | Class II | 2021-05-28 |
| K210188 | coraCross | Reflow Medical | DQY | Class II | 2021-05-28 |
| K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index | Edwards Lifesciences, LLC | DQK | Class II | 2021-05-28 |
| K211134 | BIB Stent Placement Catheter | NuMED, Inc. | NVM | Class II | 2021-05-27 |
| K211253 | PlasmaWave | Manamed, Inc. | JOW | Class II | 2021-05-26 |
| K211251 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | DQY | Class II | 2021-05-26 |
| K203724 | HeRO Graft, HeRO Adapter | Merit Medical Systems, Inc. | DSY | Class II | 2021-05-25 |
| K210608 | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | MXD | Class II | 2021-05-25 |
| K202359 | Zio Monitor | iRhythm Technologies, Inc. | DSH | Class II | 2021-05-21 |
| K210358 | Neurescue device | Neurescue Aps | MJN | Class II | 2021-05-21 |
| K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | DQK | Class II | 2021-05-21 |
| K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | MWI | Class II | 2021-05-20 |
| K203440 | Penumbra System (Reperfusion Catheter RED 62) | Penumbra, Inc. | NRY | Class II | 2021-05-20 |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | Bio Compression Systems, Inc. | JOW | Class II | 2021-05-14 |
| K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | DRA | Class II | 2021-05-14 |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | DRT | Class II | 2021-05-14 |
| K210435 | Automatic Arm Electronic Blood Pressure Monitor | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | DXN | Class II | 2021-05-12 |
| K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | 2021-05-12 |
| K203847 | Reprocessed Tri Pulse Compression Garment | Renu Medical, Inc. | JOW | Class II | 2021-05-07 |
| K202578 | KardiFlex NC Coronary Dilatation Catheter | Medcaptain Life Science Co., Ltd. | LOX | Class II | 2021-05-06 |
| K203529 | VASSALLO GT Hybrid | Filmecc Co., Ltd. | DQX | Class II | 2021-05-04 |
| K210669 | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | DTX | Class II | 2021-05-04 |
| K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | Innovative Health, LLC | NLH | Class II | 2021-05-04 |
| K203409 | MC3 Crescent Jugular Dual Lumen Catheter | Mc3, Inc. | PZS | Class II | 2021-05-03 |
| K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 | Inari Medical, Inc. | QEW | Class II | 2021-04-30 |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | Vascular Solutions, LLC | DQY | Class II | 2021-04-30 |
| K203786 | MAC 7 - Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | DPS | Class II | 2021-04-30 |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | LOX | Class II | 2021-04-29 |
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | 3M Company | DWJ | Class II | 2021-04-29 |
| K210601 | Plato 17 Microcatheter | Scientia Vascular, LLC | DQY | Class II | 2021-04-28 |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor | Contec Medical Systems Co.,Ltd | DXN | Class II | 2021-04-28 |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | DRT | Class II | 2021-04-26 |
| K210885 | Dayspring | Koya Medical, Inc. | JOW | Class II | 2021-04-23 |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | NRY | Class II | 2021-04-23 |
| K203854 | Pulse Oximeter | Shenzhen Hexin Zondan Medical Equipment Co., Ltd. | DQA | Class II | 2021-04-23 |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | Cordis Corporation | LIT | Class II | 2021-04-23 |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | 2021-04-22 |
| K203353 | DVT-PRO | Daesung Maref Co., Ltd. | JOW | Class II | 2021-04-22 |
| K203533 | VASSALLO GT | Filmecc Co., Ltd. | DQX | Class II | 2021-04-21 |
| K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | PDU | Class II | 2021-04-20 |
| K203473 | SOZO | ImpediMed Limited | DSB | Class II | 2021-04-19 |
| K210235 | Verrata PLUS Pressure Guide Wire | Volcano Corporation | DQX | Class II | 2021-04-15 |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | KRA | Class II | 2021-04-15 |
| K203390 | Artimes pro Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | LOX | Class II | 2021-04-14 |
| K202729 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2021-04-08 |
| K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | DYB | Class II | 2021-04-06 |
| K210734 | Endovascular Dilator and Sets | Cook Incorporated | DRE | Class II | 2021-04-06 |
| K210681 | SiteSeal SV | Ensite Vascular | DXC | Class II | 2021-04-06 |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | Vascutek, Ltd. | DSY | Class II | 2021-04-06 |
| K210130 | Stockert S5 System | Livanova Deutschland, GmbH | DTQ | Class II | 2021-04-05 |
| K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | JOW | Class II | 2021-04-02 |
| DEN200038 | Gili Pro BioSensor (also known as Gili BioSensor System) | Continuse Biometrics , Ltd. | QOK | Class II | 2021-04-01 |
| K202206 | AMG PMP Pediatric | Eurosets S.R.L | DTZ | Class II | 2021-04-01 |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | DXN | Class II | 2021-04-01 |
| K202154 | B-Capta | Livanova Deutschland, GmbH | DRY | Class II | 2021-04-01 |
| K210110 | Guidion | Imds Operations B.V. | DQY | Class II | 2021-03-31 |
| K210603 | 3M Bair Hugger Temperature Management System (Model 675) | 3M Company | DWJ | Class II | 2021-03-30 |
| K203417 | DVT-4000S | Daesung Maref Co., Ltd. | JOW | Class II | 2021-03-28 |
| DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | QME | Class II | 2021-03-26 |
| K201921 | Spacelabs Lifescreen PRO Analyzer | Spacelabs Healthcare, Ltd. | DQK | Class II | 2021-03-26 |
| K202751 | TandemHeart Pump and Escort Controller | Cardiacassist, Inc. | QNR | Class II | 2021-03-26 |
| K202483 | MyHomeDoc | Myhomedoc , Ltd. | DQD | Class II | 2021-03-23 |
| K203620 | Aneroid Sphygmomanometer | Wuxi Exanovo Medical Instrument Co., Ltd. | DXQ | Class II | 2021-03-23 |
| K203592 | Tigertriever and Tigertriever 17 Revascularization Devce | Rapid Medical Ltd. | NRY | Class II | 2021-03-23 |
| K203052 | Movement and Compressions System (the MAC System) | Recovery Force, LLC | JOW | Class II | 2021-03-21 |
| K210392 | WorkMate Claris System | Abbott | DQK | Class II | 2021-03-11 |
| K193663 | FloPump 57mL Centrifugal Pump | International Biophysics Corporation | KFM | Class II | 2021-03-10 |
| K202891 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2021-03-09 |
| K202375 | ZOLL Propaq M | ZOLL Medical Corporation | MWI | Class II | 2021-03-09 |
| K202125 | Century Perfusion System | Century Hlm, LLC | DTQ | Class II | 2021-03-07 |
| K201581 | CPR BAND | Credo | LIX | Class II | 2021-03-06 |
| K210328 | SafeSept Blunt Needle | Pressure Products Medical Device Manufacturing, LLC | DRC | Class II | 2021-03-05 |
| K201775 | NuVision ICE Catheter | Nuvera Medical, Inc. | OBJ | Class II | 2021-03-05 |
| K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | DRF | Class II | 2021-03-05 |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | Carefusion 2200, Inc. | DXC | Class II | 2021-03-04 |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | DXC | Class II | 2021-03-04 |
| K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform | Imperative Care, Inc. | QJP | Class II | 2021-03-03 |
| K203521 | FineCross M3 | Ashitaka Factory of Terumo Corporation | DQY | Class II | 2021-03-03 |
| K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | NTE | Class II | 2021-03-03 |
| K202776 | Fingertip pulse oximeter | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | DQA | Class II | 2021-03-01 |
| DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye, Inc. | QNV | Class II | 2021-03-01 |
| K202743 | Med-Link Temp-pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | DQA | Class II | 2021-03-01 |
| K203275 | Recon Support Catheter | C.R. Bard, Inc. | DQY | Class II | 2021-03-01 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.