Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 47
- Latest Decision
- 2020-07-28
Clearances · page 23 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201794 | Jade | OrbusNeich Medical (Shenzhen) Co., Ltd. | LIT | Class II | 2020-07-28 |
| K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | KRA | Class II | 2020-07-28 |
| K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | LDD | Class II | 2020-07-24 |
| K201713 | AVVIGO Guidance System | Boston Scientific Corporation | DQK | Class II | 2020-07-23 |
| K200738 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2020-07-23 |
| K192998 | Reprocessed BRK Transseptal Needle | Innovative Health, LLC | NMK | Class II | 2020-07-22 |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | Surgical Instrument and Savings Inc (Dba Medline Renewal) | NLF | Class II | 2020-07-22 |
| K193607 | BOBBY Balloon Guide Catheter | MicroVention, Inc. | DQY | Class II | 2020-07-21 |
| K201689 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | 2020-07-21 |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQX | Class II | 2020-07-21 |
| K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | Covidien, LLC | DQA | Class II | 2020-07-20 |
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Codman & Shurtleff, Inc. | NRY | Class II | 2020-07-20 |
| K193456 | Arm Blood Pressure Monitor | Ningbo Ranor Medical Science & Technology Co., Ltd. | DXN | Class II | 2020-07-16 |
| K200690 | LifeSignals ECG Remote Monitoring Patch Platform | Lifesignals, Inc. | DRG | Class II | 2020-07-15 |
| K193063 | EMBOTRAP III Revascularization Device | Neuravi, Ltd. | NRY | Class II | 2020-07-14 |
| K193627 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | DXN | Class II | 2020-07-12 |
| K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | DXN | Class II | 2020-07-12 |
| K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | MWI | Class II | 2020-07-10 |
| K201299 | HD Steth | Hd Medical, Inc. | DQD | Class II | 2020-07-10 |
| K200568 | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System | B&J Manufacturing , Ltd. | JOW | Class II | 2020-07-10 |
| K193624 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | DXN | Class II | 2020-07-10 |
| K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | B&J Manufacturing , Ltd. | JOW | Class II | 2020-07-08 |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | DXZ | Class II | 2020-07-08 |
| K201216 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | 2020-07-08 |
| K200537 | Oxxiom | True Wearables, Inc. | DQA | Class II | 2020-07-03 |
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | Medtronic, Inc. | MXD | Class II | 2020-07-03 |
| K200285 | VenaOne | Vena Group, LLC | JOW | Class II | 2020-07-02 |
| K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector | Atrility Medical, LLC | DSA | Class II | 2020-07-02 |
| K201487 | Traxcess 7 Mini Guidewire | MicroVention, Inc. | MOF | Class II | 2020-07-02 |
| K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | IZQ | Class II | 2020-07-02 |
| K193259 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Little Doctor Electronic (Nantong)Co.,Ltd | DXQ | Class II | 2020-07-02 |
| K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | Medtronic, Inc. | KRH | Class II | 2020-07-01 |
| K193632 | LassoStar Circular Mapping Catheter | Biosense Webster, Inc. | DRF | Class II | 2020-06-30 |
| K193119 | Twin-Pass Dual Access Catheter | Vascular Solutions, LLC | DQY | Class II | 2020-06-29 |
| K192900 | H500 Multi-Sensing Oximetry System | Nonin Medical, Inc. | DQA | Class II | 2020-06-29 |
| K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US | Boston Scientific Corporation | MXD | Class II | 2020-06-26 |
| K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | ABBOTT MEDICAL | DQK | Class II | 2020-06-26 |
| K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License | ABBOTT MEDICAL | DQK | Class II | 2020-06-26 |
| K193348 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | DXN | Class II | 2020-06-25 |
| K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | KRA | Class II | 2020-06-25 |
| K200437 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | DXN | Class II | 2020-06-25 |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Northeast Scientific, Inc. | OBJ | Class II | 2020-06-22 |
| K192404 | Patient Monitoring Cable (SpO2 Extension Cable) | Shenzhen Coreray Technology, Ltd. | DSA | Class II | 2020-06-22 |
| K192337 | Zeroveno | Dimedi Co., Ltd. | JOW | Class II | 2020-06-22 |
| K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | DTR | Class II | 2020-06-19 |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2020-06-18 |
| K193620 | OptoMonitor 3 | Opsens, Inc. | DXO | Class II | 2020-06-18 |
| K193288 | Koya Ripple | Koya, Inc. | JOW | Class II | 2020-06-16 |
| K201116 | Abiomed 23 Fr Sheath | Abiomed, Inc. | DYB | Class II | 2020-06-15 |
| K200446 | STERIS Patient Warming System | STERIS Corporation | DWJ | Class II | 2020-06-13 |
| K200521 | Full Automatic(NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2020-06-12 |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir | Sorin Group Italia S.R.L. | DTZ | Class II | 2020-06-12 |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | Edwards Lifesciences, LLC | DXE | Class II | 2020-06-12 |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | DRE | Class II | 2020-06-12 |
| K193415 | physIQ Heart Rhythm and Respiration Module | Physiq, Inc. | DPS | Class II | 2020-06-11 |
| K201271 | Benchmark BMX96 Access System | Penumbra, Inc. | DQY | Class II | 2020-06-11 |
| K200015 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2020-06-08 |
| K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | MSX | Class II | 2020-06-05 |
| K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | DQY | Class II | 2020-06-03 |
| K200268 | Halo Single-Loop Snare Kit | Argon Medical Devices, Inc. | MMX | Class II | 2020-06-03 |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | MJN | Class II | 2020-06-03 |
| K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | QEY | Class II | 2020-06-01 |
| K191620 | Vitls Platform | Vitls, Inc. | DRG | Class II | 2020-06-01 |
| K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | PNO | Class II | 2020-05-29 |
| K190982 | Automatic Digital Blood Pressure Monitor | Xiamen Ants Bro Technology Co., Ltd. | DXN | Class II | 2020-05-29 |
| K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific | DQK | Class II | 2020-05-29 |
| K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | Penumbra, Inc. | QEW | Class II | 2020-05-28 |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | Arrow International, Inc. | DSP | Class II | 2020-05-27 |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | Philips Image Guided Therapy Corporation | OBJ | Class II | 2020-05-22 |
| K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MSX | Class II | 2020-05-21 |
| K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface | Medtronic, Inc. | KFM | Class II | 2020-05-21 |
| K192399 | Infinity Angioplasty Balloon Catheter | Infinity Angioplasty Balloon Company, LLC | LIT | Class II | 2020-05-20 |
| K191745 | Medtronic Commander Flex | Medtronic Care Management Services | DXN | Class II | 2020-05-15 |
| K200287 | BP-BT Kiosk | Ld Technology, LLC | DXN | Class II | 2020-05-15 |
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | Creagh Medical, Ltd. | LIT | Class II | 2020-05-14 |
| K200317 | Support Catheter | Qxmedical, LLC | DQY | Class II | 2020-05-14 |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | Stryker Sustainability Solutions | NLH | Class II | 2020-05-13 |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | 2020-05-13 |
| K200026 | Disposable ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | DSA | Class II | 2020-05-12 |
| K193043 | Critical Alert CommonPath Enterprise | Critical Alert | MSX | Class II | 2020-05-11 |
| K192972 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2020-05-07 |
| K200120 | LiteSaber Wire Torque Assist Device | Vesatek, LLC | DQX | Class II | 2020-05-07 |
| K193420 | XO Cross Support Catheter | Transit Scientific | DQY | Class II | 2020-05-06 |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | DRE | Class II | 2020-05-06 |
| K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator | Control Medical Technology | QEZ | Class II | 2020-05-04 |
| K200910 | BOSS Balloon Guide Catheter | Marblehead Medical | QJP | Class II | 2020-05-02 |
| K200417 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | QJP | Class II | 2020-05-02 |
| K200870 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | 2020-05-01 |
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | DXG | Class II | 2020-04-30 |
| K200141 | Oxi-W System | Ld Technology, LLC | MWI | Class II | 2020-04-27 |
| K193350 | Leadtek Fingertip Pulse Oximeter | Leadtek Research, Inc. | DQA | Class II | 2020-04-27 |
| K200101 | WOLF Thrombectomy V System | Devoro Medical, Inc. | QEW | Class II | 2020-04-27 |
| K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | MJN | Class II | 2020-04-25 |
| K200444 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | MXD | Class II | 2020-04-23 |
| K200771 | Indigo Aspiration System Lightning Aspiration Tubing | Penumbra, Inc. | QEW | Class II | 2020-04-22 |
| K191882 | Masimo Centroid System | Masimo Corporation | MWI | Class II | 2020-04-22 |
| K200744 | Instylla Microcatheter | Instylla, Inc. | KRA | Class II | 2020-04-21 |
| K192609 | Globalcare Blood Pressure Monitor | Globalcare Medical Technology Co., Ltd. | DXN | Class II | 2020-04-21 |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | Vitalconnect, Inc. | DRG | Class II | 2020-04-20 |
| K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | QEZ | Class II | 2020-04-20 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.