Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 46
- Latest Decision
- 2019-06-04
Clearances · page 27 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K183535 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2019-06-04 |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Physio-Control, Inc. | LDD | Class II | 2019-06-03 |
| K182660 | GaltTWS | Galt Medical Corp. | DRB | Class II | 2019-05-30 |
| K190628 | FlexSeal Introducer Sheath with Hydrophilic Coating | Freudenberg Medical Mis, Inc. | DYB | Class II | 2019-05-30 |
| K190167 | MitraClip G4 Steerable Guide Catheter | Abbott | DRA | Class II | 2019-05-29 |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor | Nihon Kohden Corporation | MWI | Class II | 2019-05-28 |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical , Ltd. | DTQ | Class II | 2019-05-24 |
| K182390 | IMPEDE-FX Embolization Plug | Shape Memory Medical | KRD | Class II | 2019-05-23 |
| K182937 | Upstream GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | DQY | Class II | 2019-05-23 |
| K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope | Wenzhou Renhua Instruments Co., Ltd. | DXQ | Class II | 2019-05-22 |
| K183646 | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure | Edwards Lifeciences, LLC | QAQ | Class II | 2019-05-21 |
| K183655 | VersaCross Transseptal Sheath | Baylis Medical Company, Inc. | DYB | Class II | 2019-05-20 |
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | Health & Life Co., Ltd. | DXN | Class II | 2019-05-20 |
| K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | DWF | Class II | 2019-05-17 |
| K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac | Medtronic, Inc. | DTZ | Class II | 2019-05-17 |
| K183534 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2019-05-16 |
| K191000 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | 2019-05-16 |
| K173895 | Tel-O-Graph | I.E.M. Industrielle Entwicklung and Medizintechnik | DXN | Class II | 2019-05-16 |
| K182532 | Liba3 System | National Cardiac, Inc. | DSI | Class II | 2019-05-15 |
| K183277 | SpO2 Sensor | Shenzhen Upnmed Equipment Co., Ltd. | DQA | Class II | 2019-05-15 |
| K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | MWI | Class II | 2019-05-15 |
| K182602 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | DQY | Class II | 2019-05-15 |
| K190974 | D'Vill Introducer | NuMED, Inc. | DYB | Class II | 2019-05-14 |
| K183319 | Triangle System | AliveCor, Inc. | DXH | Class II | 2019-05-10 |
| K181894 | TOF-Cuff monitor | Rgb Medical Devices SA | DXN | Class II | 2019-05-09 |
| K190393 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | DQY | Class II | 2019-05-09 |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions | OWQ | Class II | 2019-05-08 |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | Biocardia, Inc. | DYB | Class II | 2019-05-06 |
| K181671 | Cocoon Convective Warming System | Care Essentials Pty, Ltd. | DWJ | Class II | 2019-05-02 |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | Nonin Medical, Inc. | MUD | Class II | 2019-05-02 |
| K190843 | Synchro2 Support Guidewire | Stryker | MOF | Class II | 2019-05-01 |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | DXO | Class II | 2019-05-01 |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | 2019-04-30 |
| K183045 | Eclipse 2L | Balt USA, LLC | MJN | Class II | 2019-04-30 |
| K190619 | Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited | QEZ | Class II | 2019-04-29 |
| K190464 | Penumbra System 3D Revascularization Device | Penumbra, Inc. | NRY | Class II | 2019-04-26 |
| K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | MSX | Class II | 2019-04-26 |
| K182071 | Multi-Sideport Catheter Infusion Set | Cook Incorporated | KRA | Class II | 2019-04-25 |
| K190212 | AXS Vecta Aspiration System | Stryker Neurovascular | NRY | Class II | 2019-04-24 |
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | MJN | Class II | 2019-04-24 |
| K173065 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | DXN | Class II | 2019-04-24 |
| K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | Innovative Health, LLC | DRF | Class II | 2019-04-23 |
| K190753 | EverCrossTM 0.035 OTW PTA Dilatation Catheter | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | LIT | Class II | 2019-04-23 |
| K183613 | exGraft, exGraft Carbon | Peca Labs | DSY | Class II | 2019-04-22 |
| K182457 | Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J | Brivant Limited (Lake Region Medical) | DQX | Class II | 2019-04-18 |
| K190644 | Guide Sheath | Surmodics,Inc. | DYB | Class II | 2019-04-18 |
| K190506 | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | KRH | Class II | 2019-04-18 |
| K183634 | Stasis Monitoring System | Stasis Labs, Inc. | MWI | Class II | 2019-04-17 |
| K183043 | 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter | Imperative Care, Inc. | NRY | Class II | 2019-04-17 |
| K182944 | Dr. Amplatz Micro Plug | Ka Medical, LLC | KRD | Class II | 2019-04-17 |
| K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Company, Inc. | DYB | Class II | 2019-04-17 |
| K190369 | M-Y Sheath | Ram Medical Innovations, Inc. | DYB | Class II | 2019-04-17 |
| K183638 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie | MWI | Class II | 2019-04-17 |
| K181988 | eMurmur ID | Csd Labs GmbH | DQD | Class II | 2019-04-17 |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | DXN | Class II | 2019-04-17 |
| K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | 2019-04-17 |
| K181541 | Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK | Andon Health Co, Ltd. | MWI | Class II | 2019-04-16 |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | Sorin Group Italia S.R.L. | DTZ | Class II | 2019-04-13 |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | OGZ | Class II | 2019-04-12 |
| K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | Medtronic, Inc. | DTZ | Class II | 2019-04-12 |
| K182396 | KardiaMobile, KardiaStation | AliveCor, Inc. | DXH | Class II | 2019-04-12 |
| K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | MXC | Class II | 2019-04-10 |
| K190175 | S-MAK XL | Merit Medical Systems, Inc. | DRE | Class II | 2019-04-10 |
| K181832 | Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2019-04-09 |
| K182341 | Pantheris SV | Avinger, Inc. | MCW | Class II | 2019-04-09 |
| K190581 | Amplatzer Trevisio Intravascular Delivery System | ABBOTT MEDICAL | DQY | Class II | 2019-04-05 |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | QEY | Class II | 2019-04-05 |
| K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | MWI | Class II | 2019-04-05 |
| K181931 | GMC Upper Arm Automatic Blood Pressure Monitor | Gmc, Inc. | DXN | Class II | 2019-04-04 |
| K182399 | Park Blade Septostomy Catheter | Cook Incorporated | DXF | Class II | 2019-04-04 |
| K190557 | Bio-Medicus Insertion Kit | Medtronic, Inc. | DWF | Class II | 2019-04-03 |
| K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2019-04-02 |
| K181352 | Loop System | Spry Health, Inc. | DQA | Class II | 2019-03-29 |
| K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott | MXC | Class II | 2019-03-29 |
| K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | MWI | Class II | 2019-03-29 |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub | Current Health , Ltd. | MSX | Class II | 2019-03-27 |
| K182835 | WOLF Thrombectomy Device | 880 Medical, LLC | QEW | Class II | 2019-03-27 |
| K182821 | Accutorr 7/VS-900/VS-900c Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MWI | Class II | 2019-03-27 |
| K181882 | eKuore One electronic interface for stethoscope | Chip Ideas Electronics S.L. | DQD | Class II | 2019-03-27 |
| K181658 | MobileECG 2 BT | Memtec Corporation | DSI | Class II | 2019-03-26 |
| K181817 | transGlideXT Expandable Introducer | Transaortic Medical, Inc. | DYB | Class II | 2019-03-26 |
| K183491 | Arm Blood Pressure Monitor | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | DXN | Class II | 2019-03-24 |
| K181738 | Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors | Surgical Instrument Service and Savings Inc (Dba Medline | DQA | Class II | 2019-03-22 |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories | Masimo Corporation | DQA | Class II | 2019-03-22 |
| K181722 | Polyethylene Catheter | Cook Incorporated | DQO | Class II | 2019-03-22 |
| K183353 | Telescope Guide Extension Catheter | Medtronic, Inc. | DQY | Class II | 2019-03-22 |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile | Scientia Vascular, LLC | MOF | Class II | 2019-03-22 |
| K190431 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | DQY | Class II | 2019-03-21 |
| K182918 | Ballast 088 Long Sheath | Balt USA, LLC | DQY | Class II | 2019-03-21 |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | DRE | Class II | 2019-03-21 |
| K173191 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | DXN | Class II | 2019-03-21 |
| K190423 | Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System | Devon Medical Products (Jiangsu), Ltd. | JOW | Class II | 2019-03-19 |
| K183511 | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) | Medtronic, Inc. | DTZ | Class II | 2019-03-18 |
| K190401 | MAMBA and MAMBA Flex Microcatheters | Boston Scientific Corporation | DQY | Class II | 2019-03-15 |
| K183493 | SelectSite C304-HIS Deflectable Catheter System | Medtronic, Inc. | DQY | Class II | 2019-03-15 |
| K182571 | CardioFlux with Faraday Analytical Cloud | Genetesis, Inc. | DPS | Class II | 2019-03-15 |
| K190318 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | DXC | Class II | 2019-03-14 |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | DXN | Class II | 2019-03-14 |
| K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MSX | Class II | 2019-03-13 |
| K182570 | Venture 0.014 Catheter | Vascular Solutions, LLC | DQY | Class II | 2019-03-13 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.