Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 53
- Latest Decision
- 2016-06-10
Clearances · page 38 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K160496 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | NLH | Class II | 2016-06-10 |
| K160526 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | 2016-06-09 |
| K153719 | LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream | Honeywell Hommed, LLC | DRG | Class II | 2016-06-03 |
| K161183 | Halo One Thin-Walled Guiding Sheath | C.R. Bard, Inc. | DYB | Class II | 2016-06-03 |
| K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | DXN | Class II | 2016-06-01 |
| K153552 | AGE Automatic Upper Arm Blood Pressure Monitor | Ageless Health Industrial Co., Ltd. | DXN | Class II | 2016-06-01 |
| K161209 | Cirona 6400 | Devon Medical Products | JOW | Class II | 2016-05-31 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | Ivy Biomedical Systems, Inc. | DRT | Class II | 2016-05-27 |
| K160809 | Reveal LINQ | Medtronic, Inc. | MXD | Class II | 2016-05-26 |
| K153762 | Smartdop XT6 | Koven Technology, Inc. | JOP | Class II | 2016-05-25 |
| K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | DSI | Class II | 2016-05-25 |
| K152789 | FLEX SCORING CATHETER | Venturemed Group | PNO | Class II | 2016-05-25 |
| K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | NRY | Class II | 2016-05-25 |
| K153162 | Hypocore | Novocor Medical Systems, Inc. | NCX | Class II | 2016-05-24 |
| K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | QEW | Class II | 2016-05-24 |
| K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | PDU | Class II | 2016-05-24 |
| K160889 | BIB Stent Placement Catheter | NuMED, Inc. | NVM | Class II | 2016-05-20 |
| K161125 | OptiCross X, 40 MHz Coronary Imaging Catheter | Boston Scientific Corporation | OBJ | Class II | 2016-05-19 |
| K161102 | Nanostim Introducer Kit | St. Jude Medical, Inc. | DYB | Class II | 2016-05-19 |
| K153778 | Nester Embolization Coils, Tornado Embolization Coils | Cook Incorporated | KRD | Class II | 2016-05-19 |
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager | Moor Instruments, Ltd. | DPT | Class II | 2016-05-12 |
| K153703 | Guiding Catheter | Texasmedical Technologies, Inc. | DQY | Class II | 2016-05-12 |
| K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | Class II | 2016-05-12 |
| K150980 | Venous Assist System | Daesung Maref Co., Ltd. | JOW | Class II | 2016-05-12 |
| K160303 | Reprocessed Polaris X Steerable Diagnostic EP Catheter | Innovative Health, LLC | NLH | Class II | 2016-05-10 |
| K160242 | Reprocessed Livewire Steerable Diagnostic EP Catheter | Innovative Health, LLC | NLH | Class II | 2016-05-10 |
| K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | Medtronic, Inc. | DRF | Class II | 2016-05-06 |
| K152043 | Diagnostic Station DS20 | Schiller AG | DPS | Class II | 2016-05-06 |
| K152415 | Digital Blood Pressure Monitor | Suzhou Sunspirit Co., Ltd. | DXN | Class II | 2016-05-06 |
| K152006 | Cogent Hemodynamic Monitoring System | Icu Medical, Inc. | DXQ | Class II | 2016-05-05 |
| K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | MHX | Class II | 2016-05-05 |
| K152930 | PeriFlux6000 | Perimed AB | DPW | Class II | 2016-05-05 |
| K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | DYG | Class II | 2016-05-03 |
| K160013 | Crosperio OTW | KANEKA Corporation | LIT | Class II | 2016-04-29 |
| K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit | C.R. Bard, Inc. | DTK | Class II | 2016-04-29 |
| K152973 | Dyna-Vision Telemonitoring System | Techmedic Development International B.V. | MHX | Class II | 2016-04-29 |
| K160004 | Crosstella OTW | KANEKA Corporation | LIT | Class II | 2016-04-29 |
| K152552 | Patient Monitor | Edan Instruments, Inc. | MHX | Class II | 2016-04-29 |
| K152934 | MMS PTA Balloon Catheter | Micro Medical Solutions, Inc. | LIT | Class II | 2016-04-25 |
| K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | 2016-04-22 |
| K160689 | Reveal LINQ | Medtronic, Inc. | MXD | Class II | 2016-04-22 |
| K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | DSI | Class II | 2016-04-22 |
| K160827 | Pantheris Catheter | Avinger, Inc. | MCW | Class II | 2016-04-21 |
| K152563 | Pulse Oximeter (MD300M/MD300K2) | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2016-04-18 |
| K153501 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | KRA | Class II | 2016-04-15 |
| K160716 | The Nanostim Introducer Kit | St. Jude Medical, Inc. | DYB | Class II | 2016-04-14 |
| K153251 | Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff | Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. | DXQ | Class II | 2016-04-14 |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit | Medtronic, Inc. | MAV | Class II | 2016-04-13 |
| K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | A&D Company, Ltd. | DXN | Class II | 2016-04-13 |
| K152107 | HealthChek Network Health Station | Healthchek Network, LLC | DXN | Class II | 2016-04-12 |
| K160390 | Map-it Diagnostic Mapping Catheters | Access Point Technologies Ep, Inc. | DRF | Class II | 2016-04-11 |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | MXD | Class II | 2016-04-11 |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | DSI | Class II | 2016-04-08 |
| K153093 | FIRMap Catheter | Abbott Electrophysiology | MTD | Class II | 2016-04-07 |
| K152194 | transGlide Expandable Introducer | Transaortic Medical, Inc. | DYB | Class II | 2016-04-07 |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | Asahi Intecc Co., Ltd. | MOF | Class II | 2016-04-07 |
| K152864 | Merge Hemo | Merge Healthcare Incorporated | DQK | Class II | 2016-04-07 |
| K152947 | Disposable Temporary Pacing Cable | Tiger Medical Products | DSA | Class II | 2016-04-05 |
| K152228 | Hydroven 12, Hydroven 12 Garments | Huntleigh Healthcare , Ltd. | JOW | Class II | 2016-04-04 |
| K160318 | PlasmaFlow | Manamed, Inc. | JOW | Class II | 2016-04-01 |
| K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM | Spacelabs Healthcare, Ltd. | DQK | Class II | 2016-04-01 |
| K152258 | T3 Software | Etiometry, Inc. | PLB | Class II | 2016-03-31 |
| K153160 | AVIVO Mobile Patient Management (MPM) System | Medtronic, Inc. | MHX | Class II | 2016-03-30 |
| K160336 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2016-03-29 |
| K152978 | DeRoyal Angiography Kits | Deroyal Industries, Inc. | DXT | Class II | 2016-03-25 |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | NCX | Class II | 2016-03-24 |
| K152090 | Reprocessed Steerable Introducer | Sterilmed, Inc. | PNE | Class II | 2016-03-23 |
| K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor | Caretaker Medical, LLC | DXN | Class II | 2016-03-18 |
| K152999 | CorPath 200 System | Corindus, Inc. | DXX | Class II | 2016-03-18 |
| K152935 | LiDCOunity Monitor | Lidco, Ltd. | DXG | Class II | 2016-03-17 |
| K153079 | Axeo 3 Patient Monitor | Axeo Medical Technologies, LLC | MWI | Class II | 2016-03-17 |
| K151135 | MODEL 621/624 BIOMAGNETOMETER | Tristan Technologies, Inc. | DPS | Class II | 2016-03-15 |
| K153335 | AlertWatch: OR | Alertwatch, LLC | MWI | Class II | 2016-03-15 |
| K153153 | Reprocessed Electrophysiology Catheter | Innovative Health, LLC | NLH | Class II | 2016-03-14 |
| K160145 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2016-03-13 |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | QYX | Class II | 2016-03-11 |
| K160389 | NovaCross Microcatheter | Nitiloop , Ltd. | DQY | Class II | 2016-03-11 |
| K160662 | Surefire Infusion System | Surefire Medical, Inc. | DQO | Class II | 2016-03-11 |
| K153090 | Reprocessed Diagnostic Ultrasound Catheter | Innovative Health, LLC | OWQ | Class II | 2016-03-10 |
| K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | NTE | Class II | 2016-03-10 |
| K152625 | MMS Guide Catheter | Micro Medical Solutions, Inc. | KRA | Class II | 2016-03-09 |
| K150876 | Bead Block | Biocompatibles UK , Ltd. | KRD | Class II | 2016-03-07 |
| K153430 | Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select | Cook Incorporated | DYB | Class II | 2016-03-07 |
| K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | DYB | Class II | 2016-03-04 |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | Cardiacassist, Inc. | DWF | Class II | 2016-03-04 |
| K152957 | MultiCross Catheter | Roxwood Medical, Inc. | DQY | Class II | 2016-03-04 |
| K152249 | ASAHI Corsair Armet | Asahi Intecc Co., Ltd. | DQY | Class II | 2016-03-04 |
| K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2016-03-03 |
| K151024 | Finger Type Pulse Oximeter | Taidoc Technology Corporation | DQA | Class II | 2016-03-02 |
| K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | MCW | Class II | 2016-03-01 |
| K153295 | TandemLung Oxygenator | Cardiacassist, Inc. | DTZ | Class II | 2016-02-26 |
| K152765 | VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM | B. Braun Interventional Systems, Inc. | DTK | Class II | 2016-02-26 |
| K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) | Boston Scientific Corporation | DXK | Class II | 2016-02-26 |
| K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | MWJ | Class II | 2016-02-26 |
| K153275 | Aingeal Activity System | Intelesens, Ltd. | MHX | Class II | 2016-02-26 |
| K153443 | ASAHI Astato XS 40 | Asahi Intecc Co., Ltd. | DQX | Class II | 2016-02-25 |
| K153488 | Occlusion Perfusion Catheter | Advanced Catheter Therapies, Inc. | QEY | Class II | 2016-02-25 |
| K153135 | VITAL SIGNS MONITOR | Guangdong Biolight Meditech Co., Ltd. | MWI | Class II | 2016-02-25 |
| K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) | Boston Scientific Corporation | OBJ | Class II | 2016-02-25 |
| K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | DRA | Class II | 2016-02-24 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.