Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 49
- Latest Decision
- 2017-04-04
Clearances · page 35 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | MJN | Class II | 2017-04-04 |
| K163459 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | MHX | Class II | 2017-04-04 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | Asahi Intecc Co., Ltd. | DQX | Class II | 2017-04-03 |
| K162820 | AC3 Series IABP System | Arrow International, Inc. | DSP | Class II | 2017-03-31 |
| K161530 | Bluetooth blood pressure monitor | Shenzhen Kingyield Technology Co., Ltd. | DXN | Class II | 2017-03-31 |
| K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | DSJ | Class II | 2017-03-31 |
| K170628 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | MXD | Class II | 2017-03-31 |
| K170635 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | LIT | Class II | 2017-03-30 |
| K170009 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | PLA | Class II | 2017-03-30 |
| K162789 | Foresight Intracardiac Echocardiology (ICE) System | Conavi Medical, Inc. | DQO | Class II | 2017-03-28 |
| K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | Cardiac Insight, Inc. | DSH | Class II | 2017-03-24 |
| K170204 | FFR Link, FFR Signal Processing Module | Boston Scientific Corporation | DRG | Class II | 2017-03-24 |
| K162023 | CardioDay V2.5 | Getemed Medizin- Und Informationstechnik AG | DQK | Class II | 2017-03-24 |
| K163314 | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter | Boston Scientific Corporation | DQY | Class II | 2017-03-23 |
| K170636 | Fathom-16 Steerable Guidewires | Boston Scientific Corporation | DQX | Class II | 2017-03-22 |
| K163608 | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm | Biostable Science & Engineering, Inc. | PST | Class II | 2017-03-21 |
| K162562 | OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY | Bcg Medical, LLC | DWJ | Class II | 2017-03-17 |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | Medtronic, Inc. | DTN | Class II | 2017-03-17 |
| K153600 | Consult Station TS | H4D Sas | DXN | Class II | 2017-03-17 |
| K161880 | NIVR58-T kit | Barco N.V. | DXJ | Class II | 2017-03-14 |
| K162589 | Adscope 658 Electronic Stethoscope | American Diagnostic Corp. | DQD | Class II | 2017-03-10 |
| K162793 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | DQK | Class II | 2017-03-10 |
| K163376 | Mikro-Cath Pressure Catheter | Millar, Inc. | DXO | Class II | 2017-03-10 |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | DXZ | Class II | 2017-03-09 |
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | Osprey Medical, Inc. | DXT | Class II | 2017-03-08 |
| K163307 | Expro Elite Snare, Sympro Elite Snare | Vascular Solutions, Inc. | MMX | Class II | 2017-03-08 |
| K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | 2017-03-08 |
| K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | Sorin Group Italia S.R.L. | DTN | Class II | 2017-03-08 |
| K170403 | CenterCross Ultra LV Catheter | Roxwood Medical, Inc. | DQY | Class II | 2017-03-07 |
| K160067 | RenovoCath | Renovorx, Inc. | MJN | Class II | 2017-03-07 |
| K160721 | Vado Steerable Sheath | Kalila Medical, Inc. | DYB | Class II | 2017-03-07 |
| K163575 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | 2017-03-03 |
| K162524 | AZUR CX Detachable 18 Peripheral Coil System | MicroVention, Inc. | KRD | Class II | 2017-03-03 |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | 2017-03-03 |
| K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | DTA | Class II | 2017-02-28 |
| K163709 | FIRMap Catheter | Abbott Electrophysiology | MTD | Class II | 2017-02-28 |
| K170373 | Flextra Steerable Introducer | Rhythm Xience, Inc. (Rxi) | DYB | Class II | 2017-02-27 |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | QEY | Class II | 2017-02-24 |
| K162855 | Reveal LINQ | Medtronic, Inc. | MXD | Class II | 2017-02-23 |
| K163535 | my Patch sl | Dms-Service, LLC | DSH | Class II | 2017-02-22 |
| K163051 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | 2017-02-21 |
| K170258 | SpeedLyser Infusion Catheter Kit | AngioDynamics, Inc. | QEY | Class II | 2017-02-21 |
| K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | DXN | Class II | 2017-02-21 |
| K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | DQY | Class II | 2017-02-18 |
| K162875 | Sentry IVC filter | Novate Medical , Ltd. | DTK | Class II | 2017-02-17 |
| K162481 | RF1400 Active Compression Wrap | Recovery Force, LLC | JOW | Class II | 2017-02-16 |
| K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | 2017-02-16 |
| K160876 | PC ECG | Edan Instruments, Inc. | DPS | Class II | 2017-02-15 |
| K162668 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2017-02-14 |
| K163460 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | MXD | Class II | 2017-02-14 |
| K170193 | Advance 14LP Low Profile PTA Balloon Dilatation Catheter | Cook Incorporated | LIT | Class II | 2017-02-13 |
| K163380 | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | PNO | Class II | 2017-02-13 |
| K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | Medtronic, Inc. | DTR | Class II | 2017-02-10 |
| K162089 | Blood Pressure Monitor | Beijing Choice Electronic Technology Co., Ltd. | DXN | Class II | 2017-02-10 |
| K163478 | AcuNav Volume ICE Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2017-02-09 |
| K161577 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | DXN | Class II | 2017-02-08 |
| K162915 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2017-02-08 |
| K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) | Bluepoint Medical GmbH & Co. KG | DQA | Class II | 2017-02-06 |
| K161901 | TrapLiner catheter | Vascular Solutions, Inc. | DQY | Class II | 2017-02-03 |
| K161056 | Telemetry Transmitter | Edan Instruments, Inc. | MHX | Class II | 2017-02-03 |
| K163268 | FlexCath Select Steerable Shealth and Dilator | Medtronic Cryocath, LP | DYB | Class II | 2017-02-02 |
| K162144 | iHealth Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2017-02-01 |
| K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge | Medtronic, Inc. | DTR | Class II | 2017-02-01 |
| K162467 | Twin-Pass Torque | Vascular Solutions, Inc. | DQY | Class II | 2017-02-01 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | Datascope Corp. | DSP | Class II | 2017-01-31 |
| K163004 | Radifocus Glidewire Advantage Track | Ashitaka Factory of Terumo Coporation | DQX | Class II | 2017-01-30 |
| K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | DXJ | Class II | 2017-01-27 |
| K162427 | Vado Bi-Directional Steerable Sheath | Kalila Medical, Inc. | DYB | Class II | 2017-01-27 |
| K161967 | FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm | Callisyn Biomedical, Inc. | KRA | Class II | 2017-01-27 |
| K162842 | ASAHI PTCA Guide Wire ASAHI SUOH 03 | Asahi Intecc Co., Ltd. | DQX | Class II | 2017-01-27 |
| K162088 | Ecomed Disposable Angiographic Syringes | Ecomed Solutions, LLC | DXT | Class II | 2017-01-27 |
| K163693 | IntraClude Intra-Aortic Occlusion Device | Edwards Lifesciences, LLC | DXC | Class II | 2017-01-26 |
| K163660 | Pantera LEO | Biotronik, Inc. | LOX | Class II | 2017-01-26 |
| K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | DXC | Class II | 2017-01-25 |
| K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves | Covidien | JOW | Class II | 2017-01-19 |
| K160660 | Medline Waste Station | Medline Industries, Inc. | DQO | Class II | 2017-01-19 |
| K163113 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2017-01-19 |
| K162434 | NC Gallant PTCA Catheter | Medinol, Ltd. | LOX | Class II | 2017-01-19 |
| K162432 | Multi-Link X2 ECG Cable and Lead Wire System | Carefusion 2200, Inc. | DSA | Class II | 2017-01-18 |
| K163657 | Quantum Workstation | Spectrum Medical , Ltd. | DRY | Class II | 2017-01-18 |
| K163231 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | LIT | Class II | 2017-01-17 |
| K162500 | Ostial Sprit Cannulae | Spyder Medical | DWF | Class II | 2017-01-12 |
| K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | MHX | Class II | 2017-01-11 |
| K163479 | R2P Metacross RX | KANEKA Corporation | LIT | Class II | 2017-01-11 |
| K163444 | Spectre guidewire | Vascular Solutions, Inc. | DQX | Class II | 2017-01-06 |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | DRE | Class II | 2017-01-06 |
| K162253 | Trapper Exchange Device | Creganna Medical Aslo Business AS Cregganna Tactx Medical | DQY | Class II | 2017-01-06 |
| K163141 | NAMIC ClearaCIL Contrast Injection Lines | AngioDynamics, Inc. | DQO | Class II | 2017-01-06 |
| K162563 | YOGA Microcatheter | Codman & Shurtleff, Inc. | DQY | Class II | 2017-01-05 |
| K163114 | Sapphire II PRO | Orbusneich Medical, Inc. | LOX | Class II | 2017-01-05 |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters | Spectranetics, Inc. | MCW | Class II | 2017-01-05 |
| K162234 | Truscope Ultra Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | MWI | Class II | 2017-01-04 |
| K153184 | Caremed Reusable & Disposable SPO2 Sensors | Shenzhen Caremed Medical Technology Co., Ltd. | DQA | Class II | 2017-01-04 |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter | Masimo Corporation | DQA | Class II | 2016-12-28 |
| K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | DQY | Class II | 2016-12-23 |
| K163055 | Reprocessed Kendall SCD Express Foot Cuff | Covidien | JOW | Class II | 2016-12-23 |
| K160231 | Model X-100C CO-Met Oximetry System | Nonin Medical, Inc. | DQA | Class II | 2016-12-23 |
| K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | Shockwave Medical, Inc. | PPN | Class II | 2016-12-22 |
| K160981 | Patient Monitor | Edan Instruments, Inc. | MHX | Class II | 2016-12-22 |
| K153426 | Ox-Imager CS | Modulated Imaging, Inc. | MUD | Class II | 2016-12-21 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.