Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 51
- Latest Decision
- 2016-12-21
Clearances · page 36 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K161916 | TelePatch Cardiac Monitor | Medicomp, Inc. | DRG | Class II | 2016-12-21 |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled | Avinger, Inc. | MCW | Class II | 2016-12-21 |
| K162251 | Reprocessed Viking Diagnostic Electrophysiology Catheters | Innovative Health, LLC | NLH | Class II | 2016-12-21 |
| DEN160020 | CipherOx CRI Tablet | Flashback Technologies, Inc. | PPW | Class II | 2016-12-21 |
| K161237 | HyperView Hyperspectral Tissue Oxygenation Measurement System | Hypermed Imaging, Inc. | MUD | Class II | 2016-12-16 |
| K162373 | LC Bead LUMI | Biocompatibles UK Limited | KRD | Class II | 2016-12-16 |
| K163200 | Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete | Boston Scientific Corporation | LOX | Class II | 2016-12-14 |
| K163174 | Emerge PTCA Dilatation Catheter | Boston Scientific Corporation | LOX | Class II | 2016-12-14 |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D | St Jude Medical | DRF | Class II | 2016-12-13 |
| K162643 | MediGuide Technology System | St Jude Medical | DQK | Class II | 2016-12-13 |
| K160218 | AutoMark Module | St Jude Medical | DQK | Class II | 2016-12-13 |
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | LIT | Class II | 2016-12-13 |
| K160210 | EnSite Precision Cardiac Mapping System v2.0 | St Jude Medical | DQK | Class II | 2016-12-13 |
| K163154 | Traxcess 7 Mini XSoft Guidewire | MicroVention, Inc. | MOF | Class II | 2016-12-09 |
| K161827 | Reprocessed Response Diagnostic Electrophysiology Catheters | Innovative Health, LLC | NLH | Class II | 2016-12-08 |
| K160785 | Worker Guidewire | Argon Medical Devices, Inc. | DQX | Class II | 2016-12-08 |
| K161702 | Endura guidewire | Vascular Solutions, Inc. | DQX | Class II | 2016-12-06 |
| K162896 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface | Medtronic, Inc. | DTZ | Class II | 2016-12-06 |
| K161769 | Reprocessed Supreme Diagnostic Electrophysiology Catheters | Innovative Health, LLC | DRF | Class II | 2016-12-06 |
| K162418 | Pioneer Plus Catheter | Philips Volcano | PDU | Class II | 2016-12-02 |
| K152266 | Altrix Precision Temperature Management System | Stryker Medical | DWJ | Class II | 2016-12-02 |
| K162214 | Protek Solo 24 Fr Venous Cannula Set | Cardiacassist, Inc. | DWF | Class II | 2016-11-30 |
| K161431 | SimplECG | Nanowear, Inc. | DXH | Class II | 2016-11-30 |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff | Shenzhen Med-Link Electronics Tech Co., Ltd. | DXQ | Class II | 2016-11-28 |
| K161962 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | KRA | Class II | 2016-11-28 |
| K160940 | Masimo Disposable Transflectance Forehead Sensor | Masimo Corporation | DQA | Class II | 2016-11-23 |
| K161873 | Pacel Flow Directed Pacing Catheter | St Jude Medical | LDF | Class II | 2016-11-22 |
| K161408 | Compass Cast and MAP | Centurion Medical Products Corporation | DRS | Class II | 2016-11-22 |
| K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | Omron Healthcare, Inc. | DXN | Class II | 2016-11-22 |
| K153021 | Fingertip Pulse Oximeter A310 | Amemo, Inc. | DQA | Class II | 2016-11-22 |
| K162316 | Pirouette 014 | Arravasc, Ltd. | LIT | Class II | 2016-11-22 |
| K161708 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | DXN | Class II | 2016-11-22 |
| K152906 | Disposable High Pressure Injector Syringe | Wuxi Yushou Medical Appliances Co., Ltd. | DXT | Class II | 2016-11-22 |
| K160884 | CXI Support Catheter | Cook Incorporated | KRA | Class II | 2016-11-22 |
| K160594 | MRWire Guide Wire | Nano4imaging GmbH | DQX | Class II | 2016-11-22 |
| K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator | Inari Medical | QEW | Class II | 2016-11-22 |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | Sterilmed, Inc. | OWQ | Class II | 2016-11-21 |
| K160656 | CorSens | Corsens Medical , Ltd. | DXR | Class II | 2016-11-21 |
| K162230 | Fully Automatic Electronic Blood Pressure Monitor | Adon Health Co., Ltd. | DXN | Class II | 2016-11-18 |
| K161909 | IQvitals Zone | Midmark Corporation | MWI | Class II | 2016-11-17 |
| K162097 | InTRAkit | Medtronic Vascular | DYB | Class II | 2016-11-17 |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DWB | Class II | 2016-11-17 |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | Access Scientific, LLC | DYB | Class II | 2016-11-17 |
| K162892 | Achieve Advance Mapping Catheter | Medtronic, Inc. | DRF | Class II | 2016-11-15 |
| K160718 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | MWI | Class II | 2016-11-14 |
| K160190 | Sunmed Control Syringes | Sunny Medical Device (Shenzhen) Co., Ltd. | DXT | Class II | 2016-11-10 |
| K161768 | LUCAS 3 Chest Compression System | Jolife AB | DRM | Class II | 2016-11-09 |
| K162769 | Pinpoint GT Introducer Needle | C.R. Bard, Inc. | DYB | Class II | 2016-11-04 |
| K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 | Boston Scientific Corporation | LIT | Class II | 2016-11-04 |
| K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | DQK | Class II | 2016-11-04 |
| K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | KRA | Class II | 2016-11-04 |
| K160349 | Electronic Sphygmomanometer | Guangdong Biolight Meditech Co., Ltd. | DXN | Class II | 2016-11-03 |
| K160180 | Intermittent Pneumatic Compression system | Daesung Maref Co., Ltd. | JOW | Class II | 2016-11-03 |
| K160421 | Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter | Innovative Health, LLC | NLH | Class II | 2016-11-02 |
| K160561 | Boosting Catheter | Qxmedical, LLC | DQY | Class II | 2016-11-02 |
| K160746 | CARDIOLINE touchECG | Cardioline S.P.A | DPS | Class II | 2016-11-02 |
| K152472 | Disposable Pressure Transducer | Zhejiang Haisheng Medical Device Co., Ltd. | DRS | Class II | 2016-10-31 |
| K162777 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | QEY | Class II | 2016-10-31 |
| K160450 | Pleurx Pleural Catheter System | Care Fusion | DWM | Class II | 2016-10-31 |
| K161822 | Torcon NB Advantage Catheters | Cook Incorporated | DQO | Class II | 2016-10-27 |
| K160121 | CorPath GRX System | Corindus, Inc. | DXX | Class II | 2016-10-27 |
| K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter | Innovative Health, LLC | NLH | Class II | 2016-10-26 |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | Volcano Corporation | OBJ | Class II | 2016-10-26 |
| K160260 | Tempo Temporary Pacing Lead | Biotrace Medical, Inc. | LDF | Class II | 2016-10-25 |
| K162117 | NIRO-200NX DP | Hamamatsu Photonics K.K. | MUD | Class II | 2016-10-25 |
| K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | Truly Instrument Limited | DXN | Class II | 2016-10-24 |
| K153188 | Caremed patient cable and leadwires | Shenzhen Caremed Medical Technology Co., Ltd. | DSA | Class II | 2016-10-24 |
| K162027 | TRAcelet Compression Device | Medtronic Vascular | DXC | Class II | 2016-10-21 |
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | St Jude Medical | DQK | Class II | 2016-10-21 |
| K162272 | Fluent inflation device | Vascular Solutions, Inc. | MAV | Class II | 2016-10-20 |
| K160401 | Tyto Stethoscope | Tyto Care , Ltd. | DQD | Class II | 2016-10-19 |
| K151139 | EasyMap MAP Catheter | Medfact Engineering GmbH | DRF | Class II | 2016-10-18 |
| K161786 | ClearLumen II Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | 2016-10-18 |
| K160643 | ENROUTE 0.014 Guidewire | Lake Region Medical | DQX | Class II | 2016-10-18 |
| K162054 | Medtronic Temporary External Pacemaker 53401 | Medtronic, Inc. | DTE | Class II | 2016-10-18 |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Avinger, Inc. | MCW | Class II | 2016-10-18 |
| K162579 | VascuCel | Admedus Regen Pty, Ltd. | DXZ | Class II | 2016-10-14 |
| K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2016-10-14 |
| K161361 | HawkOne Directional Atherectomy System | Medtronic Vascular, Inc. | MCW | Class II | 2016-10-14 |
| K161546 | R2P SlenGuide | Ashitaka Factory of Terumo Corporation | DQY | Class II | 2016-10-14 |
| K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51 | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2016-10-14 |
| K161912 | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip | Asahi Intecc Co., Ltd. | MOF | Class II | 2016-10-14 |
| K162571 | Bioflux Software | Biotricity, Inc. | DSH | Class II | 2016-10-13 |
| K153685 | Sunmed Haemostatic Valves | Sunny Medical Device (Shenzhen) Co., Ltd. | DQX | Class II | 2016-10-13 |
| K161152 | Navien Intracranial Support Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY | Class II | 2016-10-12 |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | KRH | Class II | 2016-10-12 |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | 2016-10-12 |
| K160186 | EnSite Velocity Surface Electrode Kit | St Jude Medical | DQK | Class II | 2016-10-07 |
| K160985 | Pantera Pro | Biotronik, Inc. | LOX | Class II | 2016-10-07 |
| K161471 | MR Syringe Dual Pack for Solaris Injectors | Coeur, Inc. | DXT | Class II | 2016-10-06 |
| K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | LOX | Class II | 2016-10-06 |
| K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 | Asahi Intecc Co., Ltd. | DQX | Class II | 2016-10-06 |
| K161560 | Fingertip Pulse Oximeter MD300CN310 | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2016-10-05 |
| K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | NLH | Class II | 2016-09-30 |
| K161803 | Traxcess .007 Mini Guidewire | MicroVention, Inc. | MOF | Class II | 2016-09-30 |
| K160023 | Electronic Stethoscope DS301 | Imediplus, Inc. | DQD | Class II | 2016-09-30 |
| K153156 | eCareManager 4.0.1 | Visicu, Inc. | MSX | Class II | 2016-09-30 |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | DSK | Class II | 2016-09-26 |
| K161506 | Penumbra Aspiration System | Penumbra, Inc. | QEW | Class II | 2016-09-26 |
| K161451 | BIB Stent Placement Catheter | NuMED, Inc. | NVM | Class II | 2016-09-22 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.