Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 45
- Latest Decision
- 2020-11-13
Clearances · page 22 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | DRA | Class II | 2020-11-13 |
| DEN190029 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences | QMS | Class II | 2020-11-13 |
| K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | DQK | Class II | 2020-11-13 |
| K201985 | KardiaAI | AliveCor, Inc. | DQK | Class II | 2020-11-12 |
| K203085 | NOVA Patient Warming System | Encompass Group, LLC | DWJ | Class II | 2020-11-12 |
| K203043 | Route 92 Medical 070 Access System | Route 92 Medical, Inc. | QJP | Class II | 2020-11-11 |
| K201976 | SnapshotNIR | Kent Imaging | MUD | Class II | 2020-11-10 |
| K201669 | SimpleSENSE | Nanowear, Inc. | DXH | Class II | 2020-11-06 |
| K203025 | LOBO Vascular Occlusion System (model LOBO-5) | Okami Medical | KRD | Class II | 2020-11-05 |
| K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2020-11-04 |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | MSX | Class II | 2020-10-30 |
| K203007 | eKuore Pro Series | Chip Ideas Electronics S.L. | DQD | Class II | 2020-10-30 |
| K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | DXH | Class II | 2020-10-30 |
| K201695 | Patent Hemostasis Band (PH Band) | Medical Ingenuities | DXC | Class II | 2020-10-30 |
| K193421 | Smart Alarm Interface | Boxview, LLC | MSX | Class II | 2020-10-30 |
| K201395 | Sterile High-pressure Angiographic Syringes for single-use | Youwo (Guangzhou) Medical Device Co., Ltd. | DXT | Class II | 2020-10-28 |
| K201811 | coraForce and coraFlex Support Catheters | Reflow Medical, Inc. | DQY | Class II | 2020-10-26 |
| K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | DQO | Class II | 2020-10-23 |
| K200109 | OXY-1 System | Abiomed, Inc. | DTZ | Class II | 2020-10-23 |
| K202733 | Quantum Ventilation Module | Spectrum Medical , Ltd. | DTX | Class II | 2020-10-16 |
| K193474 | Selectra 3D Outer Guiding Catheters | Biotronik, Inc. | DQY | Class II | 2020-10-16 |
| K201595 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | 2020-10-14 |
| K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | Vyaire Medical, Inc. | DSA | Class II | 2020-10-09 |
| K193631 | Stethee Pro 1, Stethee Pro Software System | M3Dicine Pty , Ltd. | DQD | Class II | 2020-10-09 |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | LIT | Class II | 2020-10-09 |
| K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | DXN | Class II | 2020-10-09 |
| K201525 | ECG App | Apple, Inc. | QDA | Class II | 2020-10-08 |
| K202584 | iSleeve Introducer Set | Boston Scientific Corporation | DYB | Class II | 2020-10-06 |
| K202253 | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | KRH | Class II | 2020-10-06 |
| K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device | Boston Scientific Corporation | QEW | Class II | 2020-10-02 |
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | DSB | Class II | 2020-10-02 |
| K202557 | Quantum Workstation 12 Elite | Spectrum Medical , Ltd. | DRY | Class II | 2020-10-02 |
| K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | DQK | Class II | 2020-10-01 |
| K201359 | ECG Cables and Leadwires | Xinkang Medical Instrument Co. , Ltd. | DSA | Class II | 2020-10-01 |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | Philips Medical Systems | DPS | Class II | 2020-09-29 |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | Volcano Corporation | DQX | Class II | 2020-09-28 |
| K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | QJP | Class II | 2020-09-28 |
| K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | MOF | Class II | 2020-09-25 |
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | Masimo Corporation | DQA | Class II | 2020-09-24 |
| K200414 | Pulse Oximeter | Shenzhen Aeon Technology Co., Ltd. | DQA | Class II | 2020-09-23 |
| K201208 | Halo AF Detection System | Livmor | DXH | Class II | 2020-09-23 |
| K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | QEW | Class II | 2020-09-21 |
| K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | Bioland Technology, Ltd. | DXN | Class II | 2020-09-21 |
| K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | B&J Manufacturing , Ltd. | JOW | Class II | 2020-09-19 |
| K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | MHX | Class II | 2020-09-18 |
| K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | Chalice Medical , Ltd. | DTZ | Class II | 2020-09-18 |
| K201547 | B&J DVT Foot Garments, Models 820 Series | B&J Manufacturing , Ltd. | JOW | Class II | 2020-09-18 |
| K201298 | VX1 | Volta Medical | DQK | Class II | 2020-09-16 |
| K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | QEY | Class II | 2020-09-15 |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | MTD | Class II | 2020-09-15 |
| K201170 | Athletis PTA Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | 2020-09-15 |
| K200313 | VIVO | Catheter Precision, Inc. | DQK | Class II | 2020-09-14 |
| K200862 | Feelix Stethoscope | Sonavi Labs, Inc. | DQD | Class II | 2020-09-14 |
| K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | KRA | Class II | 2020-09-14 |
| K202187 | FLEX Vessel Prep System | Venturemed Group, Inc. | PNO | Class II | 2020-09-11 |
| K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | DWJ | Class II | 2020-09-11 |
| K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2020-09-11 |
| K200948 | Fitbit ECG App | Fitbit, Inc. | QDA | Class II | 2020-09-11 |
| K201333 | SABER .035 PTA Dilatation Catheter | Cordis Corporation | LIT | Class II | 2020-09-11 |
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | PDU | Class II | 2020-09-10 |
| K193462 | ClotTriever Thrombectomy System | Inari Medical | QEW | Class II | 2020-09-09 |
| K202252 | ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), | Asahi Intecc Co., Ltd. | DQY | Class II | 2020-09-08 |
| K202197 | Astopad Patient Warming System | Stihler Electronic GmbH | DWJ | Class II | 2020-09-04 |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | MTD | Class II | 2020-09-03 |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | Philips Image Guided Therapy Corporation | OBJ | Class II | 2020-09-02 |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | MLO | Class II | 2020-09-02 |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | Qura S.R.L | KFM | Class II | 2020-09-02 |
| K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | NRY | Class II | 2020-09-02 |
| K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) | Penumbra, Inc. | NRY | Class II | 2020-08-31 |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | 2020-08-29 |
| K200859 | Infinity M300 | Draeger Medical Systems, Inc. | MHX | Class II | 2020-08-28 |
| K202108 | External Counterpulsation System, Soulaire | Vamed Medical Instrument Co., Ltd. | DRN | Class II | 2020-08-28 |
| K201162 | Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | DXJ | Class II | 2020-08-27 |
| K193653 | Hydrophilic Coating Guide Wire | Suzhou Hengrui Disheng Medical Co., Ltd. | DQX | Class II | 2020-08-26 |
| K193177 | CER-S | Cardiocalm | MLO | Class II | 2020-08-26 |
| K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | 2020-08-20 |
| K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co. , Ltd. | DQA | Class II | 2020-08-19 |
| K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | Penumbra, Inc. | QEW | Class II | 2020-08-19 |
| K193476 | VariLymph 12 pro | Slk Medical GmbH | JOW | Class II | 2020-08-19 |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | QEY | Class II | 2020-08-17 |
| K201518 | Route 92 Medical 088 Access System | Route 92 Medical | QJP | Class II | 2020-08-14 |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | Sorin Group Italia S.R.L. | DTZ | Class II | 2020-08-13 |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | MWI | Class II | 2020-08-10 |
| K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | DXT | Class II | 2020-08-07 |
| K193082 | Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. | KRA | Class II | 2020-08-07 |
| K201907 | ClariVein IC | Merit Medical Systems, Inc. | KRA | Class II | 2020-08-06 |
| K200353 | ManaFlow | Manamed, Inc. | JOW | Class II | 2020-08-06 |
| K200324 | NHancer Rx | Imds Operations B.V. | DQY | Class II | 2020-08-06 |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | MTD | Class II | 2020-08-06 |
| K201076 | Anchor Dual Lumen Guidewire Catheter | Aqure Medical, Inc. | QJP | Class II | 2020-08-06 |
| K191955 | Enhanced External Counter Pulsation Device Plus Omay-A | Omay(Guangzhou)Med Technologies Co., Ltd. | DRN | Class II | 2020-08-05 |
| K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | QDA | Class II | 2020-08-04 |
| K192712 | Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter | Medtronic, Inc. | DQY | Class II | 2020-08-03 |
| K200649 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2020-08-03 |
| K193237 | Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. | MTD | Class II | 2020-07-31 |
| K201834 | HI-TORQUE PROCEED Guide Wire Family | Abbott Vascular | DQX | Class II | 2020-07-30 |
| K200060 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | QLZ | Class II | 2020-07-30 |
| K201040 | Bioflux Software II | Biotricity | DSH | Class II | 2020-07-29 |
| K193647 | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | DQO | Class II | 2020-07-29 |
| K201760 | Zoom 14 Guidewire | Scientia Vascular, LLC | DQX | Class II | 2020-07-29 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.