Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 45
- Latest Decision
- 2021-02-28
Clearances · page 21 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201644 | QardioCore | Qardio, Inc. | DSH | Class II | 2021-02-28 |
| K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | Penumbra, Inc. | QEW | Class II | 2021-02-26 |
| K202167 | Brite Tip Radianz Guiding Sheath | Cordis Corporation | DYB | Class II | 2021-02-26 |
| K200567 | ASI Plethysmogrpah Analyzer | Arterial Stiffness, Inc. | JOM | Class II | 2021-02-26 |
| K210230 | Phenom Catheters | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | DQY | Class II | 2021-02-25 |
| K210195 | Triever Catheters | Inari Medical | QEW | Class II | 2021-02-24 |
| K210190 | ClotTriever Thrombectomy System | Irani Medical, Inc. | QEW | Class II | 2021-02-23 |
| K201652 | COBRA-OS Kit | Front Line Medical Technologies, Inc. | MJN | Class II | 2021-02-22 |
| K201720 | LiPPS Analyzer, LiPPS Wire Pressure Guide Wire | Beijing Bywave Sensing Medical Technology Co., Ltd. | DQX | Class II | 2021-02-18 |
| K203307 | VIOLA | Vascular Graft Solutions, Ltd. | DXC | Class II | 2021-02-17 |
| K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | KRA | Class II | 2021-02-16 |
| K203670 | Extra Large Check-Flo Introducer | Cook Incorporated | DYB | Class II | 2021-02-16 |
| K200160 | 740 SafeSAT | Zoe Medical, Inc. | MWI | Class II | 2021-02-15 |
| K193662 | Ezlymph, Ezlymph M | Eezcare Medical Corp | JOW | Class II | 2021-02-11 |
| K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | MUD | Class II | 2021-02-10 |
| K201332 | Meditech ABPM-06 (BP6) | Meditech , Ltd. | DXN | Class II | 2021-02-10 |
| K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 | Penumbra, Inc. | QEW | Class II | 2021-02-09 |
| K202850 | Concerto Versa, Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | KRD | Class II | 2021-02-09 |
| K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | MWI | Class II | 2021-02-06 |
| K210036 | Carnation Ambulatory Monitor (CAM) | Bardy Diagnostics, Inc. | DSH | Class II | 2021-02-05 |
| K203635 | Patient Monitoring Cables | Jkh USA, LLC | DSA | Class II | 2021-02-05 |
| K202366 | MAGIC Infusion Catheter | Balt USA, LLC | KRA | Class II | 2021-01-29 |
| K200289 | Michler-Kapp Cardiovascular Vent Catheter | Kapp Surgical Instrument, Inc. | DWF | Class II | 2021-01-28 |
| K203840 | BOSS 8F Balloon Guide Catheter | Marblehead Medical, LLC | QJP | Class II | 2021-01-28 |
| K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | MWI | Class II | 2021-01-28 |
| K193386 | Wrist Electronic Sphygmomanometer | Shenzhen Changkun Technology Co., Ltd. | DXN | Class II | 2021-01-27 |
| K193387 | Arm Electronic Sphygmomanometer | Shenzhen Changkun Technology Co., Ltd. | DXN | Class II | 2021-01-27 |
| K202934 | Blood Pressure Monitor | Bioland Technology, Ltd. | DXN | Class II | 2021-01-26 |
| K203803 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | DXC | Class II | 2021-01-26 |
| K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | DQA | Class II | 2021-01-25 |
| K202336 | Patient Monitor | Edan Instruments, Inc. | MHX | Class II | 2021-01-23 |
| K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | DXN | Class II | 2021-01-22 |
| K202839 | Overlapped Compression Therapy | Jkh Health Co., Ltd. | JOW | Class II | 2021-01-21 |
| K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2021-01-19 |
| K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | Argon Medical Devices, Inc. | DYB | Class II | 2021-01-15 |
| K201085 | NeVa PV Thrombectomy Device | Vesalio | QEW | Class II | 2021-01-15 |
| K203231 | Switched Internal Paddles | Philips North America, LLC | LDD | Class II | 2021-01-11 |
| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical , Ltd. | QNL | Class II | 2021-01-09 |
| K203329 | HeartFlow Analysis | HeartFlow, Inc. | PJA | Class II | 2021-01-08 |
| K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2021-01-07 |
| K200560 | InBody | Inbody Co., Ltd. | DXN | Class II | 2021-01-06 |
| K203652 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D | Jkh USA, LLC | DXQ | Class II | 2021-01-06 |
| K201114 | Bidop 7 | Koven Technology, Inc. | DPW | Class II | 2021-01-05 |
| K200963 | Halo Single-Loop Microsnare Kit | Argon Medical Devices, Inc. | MMX | Class II | 2021-01-05 |
| K202372 | Upper Arm Electronic Blood Pressure Monitor | Conmo Electronic Company Limited | DXN | Class II | 2020-12-30 |
| K202456 | M5 Recorder | Global Instrumentation, LLC | DSH | Class II | 2020-12-29 |
| K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | MJN | Class II | 2020-12-23 |
| K203476 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | 2020-12-22 |
| K201705 | ReVene Thrombectomy Catheter | Vetex Medical, Ltd. | QEW | Class II | 2020-12-22 |
| K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set | Argon Medical Devices, Inc. | DYB | Class II | 2020-12-22 |
| K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | PNO | Class II | 2020-12-22 |
| K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | DSH | Class II | 2020-12-20 |
| K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | JOW | Class II | 2020-12-20 |
| K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | QEW | Class II | 2020-12-18 |
| K200346 | Wrist Type Blood Pressure Monitor | Avita Corporation | DXN | Class II | 2020-12-17 |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | DXT | Class II | 2020-12-17 |
| K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | Philips Medical System Nederland B.V. | DQK | Class II | 2020-12-17 |
| K202226 | Lim Precision Steerable TS, Steerable Sheath, Dilator | Keystone Heart, Ltd. | DYB | Class II | 2020-12-15 |
| K200374 | Columbus Guidewire | Rapid-Medical , Ltd. | MOF | Class II | 2020-12-14 |
| K202610 | Ventrax Delivery System | Merit Medical Systems, Inc. | DQY | Class II | 2020-12-14 |
| K202324 | Fingertip Pulse Oximeter | Shenzhen Bsx Technology Electronics Co., Ltd. | DQA | Class II | 2020-12-14 |
| K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | DQO | Class II | 2020-12-11 |
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | JOM | Class II | 2020-12-11 |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | Peca Labs | DSY | Class II | 2020-12-11 |
| K202275 | CorPath GRX System | Corindus, Inc. | DXX | Class II | 2020-12-11 |
| K203333 | Triever20 Curve Catheter | Inari Medical, Inc. | QEW | Class II | 2020-12-10 |
| K202231 | JADE | OrbusNeich Medical (Shenzhen) Co., Ltd. | LIT | Class II | 2020-12-10 |
| K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | DQK | Class II | 2020-12-08 |
| K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | MXD | Class II | 2020-12-08 |
| K202330 | Impella XR Sheath Set | Abiomed, Inc. | DYB | Class II | 2020-12-07 |
| K202173 | Pulse Oximeter | Shenzhen AOJ Medical Technology Co., Ltd. | DQA | Class II | 2020-12-07 |
| K200884 | B-Secur HeartKey Software Library | B-Secur , Ltd. | DPS | Class II | 2020-12-07 |
| K201384 | Pulse Oximeter | Shenzhen Raysintone Technology Co., Ltd. | DQA | Class II | 2020-12-07 |
| K202599 | Transtek Wrist Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2020-12-06 |
| K203016 | DVT-2600 | Daesung Maref Co., Ltd. | JOW | Class II | 2020-12-05 |
| K201541 | FlowTriever Retrieval/Aspiration System | Inari Medical | QEW | Class II | 2020-12-04 |
| K200442 | InBody | Inbody Co., Ltd. | DXN | Class II | 2020-12-04 |
| K200716 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | DXN | Class II | 2020-12-04 |
| K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | MCW | Class II | 2020-12-02 |
| K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2020-12-01 |
| K202876 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | MXC | Class II | 2020-12-01 |
| K201294 | Pulse Oximeter | Guangdong Long Yao Electronic Technology Co., Ltd. | DQA | Class II | 2020-11-27 |
| K202851 | Spo2 Sensor | Jkh USA, LLC | DQA | Class II | 2020-11-27 |
| K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | DQK | Class II | 2020-11-25 |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | ABBOTT MEDICAL | DQK | Class II | 2020-11-25 |
| K202306 | T3 Platform software | Etiometry, Inc. | MWI | Class II | 2020-11-25 |
| DEN190047 | CADScor System | Acarix A/S | QMW | Class II | 2020-11-24 |
| K201742 | eKuore One Wireless Electronic Interface for stethoscope | Chip Ideas Electronics S.L. | DQD | Class II | 2020-11-24 |
| K202943 | OptoMonitor 3 | Opsens, Inc. | DXO | Class II | 2020-11-24 |
| K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | MXC | Class II | 2020-11-23 |
| K201404 | Passio Pump Drainage System | Bearpac Medical | DWM | Class II | 2020-11-20 |
| K203179 | Fortress Introducer Sheath System | Contract Medical International, GmbH | DYB | Class II | 2020-11-20 |
| K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | DTR | Class II | 2020-11-20 |
| K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | OWQ | Class II | 2020-11-20 |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | MCW | Class II | 2020-11-19 |
| K202800 | Pacific Plus PTA Catheter | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | LIT | Class II | 2020-11-18 |
| K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | Penumbra, Inc. | QEW | Class II | 2020-11-18 |
| K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line | Sorin Group Italia S.R.L. | DWF | Class II | 2020-11-17 |
| K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | 2020-11-17 |
| K201060 | Cordiana Dx16 | Cordiana Medical Informatics AG | DQK | Class II | 2020-11-16 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.