Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 51
- Latest Decision
- 2017-07-07
Clearances · page 34 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K171698 | Smart Syringe | Osprey Medical, Inc. | DXT | Class II | 2017-07-07 |
| K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | MHX | Class II | 2017-07-07 |
| K170815 | PSA Cable | Boston Scientific Corporation | DTC | Class II | 2017-07-06 |
| K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies , Ltd. | MHX | Class II | 2017-07-06 |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Codman & Shurtleff, Inc. | DQY | Class II | 2017-07-03 |
| K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip | Asahi Intecc Co., Ltd. | MOF | Class II | 2017-07-01 |
| K171612 | ACUITY Pro Lead Delivery System | Boston Scientific Corporation | DQY | Class II | 2017-06-30 |
| K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | DSY | Class II | 2017-06-30 |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | Welch Allyn, Inc. | MHX | Class II | 2017-06-30 |
| K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | DQX | Class II | 2017-06-29 |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | Biotronik, Inc. | MXD | Class II | 2017-06-29 |
| K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | DWP | Class II | 2017-06-29 |
| K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | DPS | Class II | 2017-06-26 |
| K171188 | Ossler Exam Scope | Lr Med, Inc. | DRG | Class II | 2017-06-23 |
| K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | DQY | Class II | 2017-06-23 |
| K160899 | CoVa Monitoring System 2 | Tosense, Inc. | MWI | Class II | 2017-06-22 |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | Carefusion 303, Inc. | DSA | Class II | 2017-06-22 |
| K170933 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | 2017-06-22 |
| K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | Innovative Health, LLC | NLH | Class II | 2017-06-22 |
| K163345 | TVC Imaging System, TVC Catheter | Infraredx, Inc. | OGZ | Class II | 2017-06-21 |
| K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | Sorin Group Italia S.R.L. | DWF | Class II | 2017-06-16 |
| K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | Innovative Health, LLC | OWQ | Class II | 2017-06-16 |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System | Medtronic Vascular, Inc. | MCW | Class II | 2017-06-16 |
| K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | DXT | Class II | 2017-06-15 |
| K170992 | AcuNav V 10F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2017-06-15 |
| K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2017-06-15 |
| K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | PNO | Class II | 2017-06-14 |
| K170966 | TONOPORT VI | Par Medizintechnik GmbH & Co. KG | DXN | Class II | 2017-06-14 |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Medtronic Vascular, Inc. | OTD | Class II | 2017-06-13 |
| K162625 | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters | B. Braun Interventional Systems, Inc. | LOX | Class II | 2017-06-12 |
| K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | MCW | Class II | 2017-06-09 |
| K170996 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | DQY | Class II | 2017-06-09 |
| K170460 | Sorin Connect | Sorin Group Deutschland GmbH | DXJ | Class II | 2017-06-08 |
| K163679 | Digital Automatic Blood Pressure Monitor MD3600 | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2017-06-07 |
| K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DTQ | Class II | 2017-06-07 |
| K171335 | Venture 038 catheter | Vascular Solutions, Inc. | DQY | Class II | 2017-06-07 |
| K170155 | EK12 Algorithm | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2017-06-06 |
| K163334 | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | DXG | Class II | 2017-06-05 |
| K170995 | Electrocardiograph | Edan Instruments, Inc. | DPS | Class II | 2017-06-02 |
| K170973 | VitalWatch Software User Interface | Vitalconnect, Inc. | DRG | Class II | 2017-06-02 |
| K171308 | Tubing Pack | Medtronic, Inc. | DWF | Class II | 2017-06-02 |
| K170726 | Biopsy Forceps | Fehling Instruments GmbH & Co. KG | DWZ | Class II | 2017-06-02 |
| K170311 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | PNE | Class II | 2017-06-02 |
| K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | QYX | Class II | 2017-06-02 |
| DEN160043 | Sentinel Cerebral Protection System | Claret Medical, Inc. | PUM | Class II | 2017-06-01 |
| K162389 | Medcomp Vessel Dilator | Medcomp ( Medical Components) | DRE | Class II | 2017-06-01 |
| K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY | Class II | 2017-05-31 |
| K170658 | Lympha Press Optimal Plus | Mego Afek AC , Ltd. | JOW | Class II | 2017-05-31 |
| K170954 | Portable ECG Monitor | Contec Medical Systems Co.,Ltd | DPS | Class II | 2017-05-30 |
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | AngioDynamics, Inc. | QEY | Class II | 2017-05-30 |
| K170695 | VenaCure EVLT NeverTouch Direct Introducer Sheath | AngioDynamics, Inc. | DYB | Class II | 2017-05-30 |
| K163065 | T3 Software | Etiometry, Inc. | MWI | Class II | 2017-05-26 |
| K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | 2017-05-26 |
| K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter | Cook Incorporated | DQO | Class II | 2017-05-26 |
| K171234 | Mistral-Air Warming Unit | The Surgical Company International BV (As the 37company) | DWJ | Class II | 2017-05-26 |
| K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | JOW | Class II | 2017-05-26 |
| K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System | Osprey Medical, Inc. | DXT | Class II | 2017-05-26 |
| K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead | Medtronic | LDF | Class II | 2017-05-25 |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Smiths Medical Asd, Inc. | DRS | Class II | 2017-05-24 |
| K170514 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | MHX | Class II | 2017-05-24 |
| K163618 | INDIGO Aspiration System | Penumbra, Inc. | QEX | Class II | 2017-05-24 |
| K162463 | Matrix Data Management System | Global Instrumentation, LLC | DXN | Class II | 2017-05-24 |
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | PDU | Class II | 2017-05-24 |
| K170874 | Eko Model E5 System (EME5), Eko DUO | Eko Devices, Inc. | DQD | Class II | 2017-05-19 |
| K161272 | Supreme and Response Electrophysiology Catheters | Surgical Instrument Service and Savings, Inc. | NLH | Class II | 2017-05-18 |
| K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | DQO | Class II | 2017-05-17 |
| K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | A&D Company, Ltd. | DXN | Class II | 2017-05-17 |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | DRT | Class II | 2017-05-17 |
| K163701 | Direxion and Direxion HI-FLO Torqueable Microcatheters | Boston Scientific Corporation | KRA | Class II | 2017-05-16 |
| K170199 | Unity Network ID | GE Healthcare | MWI | Class II | 2017-05-12 |
| K163276 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2017-05-11 |
| K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | DPS | Class II | 2017-05-11 |
| K163606 | Digital Blood Pressure Monitor-Automatic Upper Arm Style | Shenzhen Combei Technology Co., Ltd. | DXN | Class II | 2017-05-09 |
| K170831 | EpiAccess System | Epiep, Inc. | DYB | Class II | 2017-05-09 |
| K163382 | Oxitone 1000 | Oxitone Medical , Ltd. | DQA | Class II | 2017-05-09 |
| K171081 | Guider Catheter Introducer | Rhythm Xience, Inc. (Rxi) | DYB | Class II | 2017-05-09 |
| K161938 | Fingertip Pulse Oximeter | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | DQA | Class II | 2017-05-08 |
| K163070 | Kent Camera | Kent Imaging, Inc. | MUD | Class II | 2017-05-05 |
| K162523 | The IQool System | Braincool AB | NZE | Class II | 2017-05-03 |
| K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | A&D Company, Ltd. | DXN | Class II | 2017-05-03 |
| K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | AngioDynamics, Inc. | DQO | Class II | 2017-04-28 |
| K162679 | IOB Temperature Management System | Iob Medical, Inc. | DWJ | Class II | 2017-04-28 |
| K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | PSQ | Class II | 2017-04-28 |
| K170616 | van Andel Dilatation Catheter | Cook Incorporated | DRE | Class II | 2017-04-28 |
| K170536 | ECG Disposable Lead Wire | APK Technology Co., Ltd. | DSA | Class II | 2017-04-24 |
| K170537 | Nexxis OR, Nexxis | Barco N.V. | DXJ | Class II | 2017-04-21 |
| K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor | Caretaker Medical, LLC | DXN | Class II | 2017-04-21 |
| K162607 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MSX | Class II | 2017-04-20 |
| K162901 | Penumbra 3D Revascularization Device | Penumbra, Inc. | NRY | Class II | 2017-04-20 |
| K163235 | HEM-9210T | Omron Healthcare, Inc. | DXN | Class II | 2017-04-20 |
| K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | DXN | Class II | 2017-04-18 |
| K170406 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | DQO | Class II | 2017-04-18 |
| K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | Edwards Lifesciences, LLC | DQK | Class II | 2017-04-14 |
| K163372 | RX Takeru Balloon Dilatation Catheter | KANEKA Corporation | LOX | Class II | 2017-04-07 |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Spectranetics, Inc. | MCW | Class II | 2017-04-07 |
| K170700 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | 2017-04-06 |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter | Mivi Neuroscience, Inc. | DQY | Class II | 2017-04-06 |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | DRA | Class II | 2017-04-06 |
| K170668 | HeartSpan Steerable Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | 2017-04-05 |
| K161712 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | DXN | Class II | 2017-04-05 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.