Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 50
- Latest Decision
- 2015-08-27
Clearances · page 41 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | Sterilmed, Inc. | NLH | Class II | 2015-08-27 |
| K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | Volcano Corporation | OBJ | Class II | 2015-08-26 |
| K152097 | Retraction Aspirator | Inari Medical | QEW | Class II | 2015-08-25 |
| K151153 | Pirouette 018 | Arravasc Limited | LIT | Class II | 2015-08-20 |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | DRA | Class II | 2015-08-18 |
| K150311 | Full Automatic (NIBP)Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2015-08-18 |
| K143613 | PaxWire Occlusion Balloon System | Accessclosure, Inc. | MJN | Class II | 2015-08-14 |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | Bayer Medical Care, Inc. | DXT | Class II | 2015-08-14 |
| K152044 | Flexor Radial Hydrophilic Introducer Access Set | Cook Incorporated | DYB | Class II | 2015-08-14 |
| K151702 | Reusable Full Silicone Cover | Laerdal Medical AS | LIX | Class II | 2015-08-13 |
| K151981 | Turnpike catheter | Vascular Solution, Inc. | DQY | Class II | 2015-08-13 |
| K150452 | ComboCath OTW PTA Dilatation Catheter | Summa Therapeutics, LLC | LIT | Class II | 2015-08-13 |
| K150564 | Spaulding Electrocardiograph 2100iQ | Spaulding Clinical Research, LLC | DPS | Class II | 2015-08-12 |
| K151776 | Central Venous Pressure System | Mespere Lifesciences, Inc. | PFA | Class II | 2015-08-12 |
| K151877 | MicroTract Access System | Arstasis, Inc. | DRE | Class II | 2015-08-07 |
| K152054 | Confida Adaptive Sheath | Medtronic, Inc. | DYB | Class II | 2015-08-07 |
| K151409 | Selectra Catheters and Selectra Accessory Kit | Biotronik, Inc. | DQY | Class II | 2015-08-07 |
| K151583 | Digital Automatic Wrist Blood Pressure Monitor MD3900 | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2015-08-07 |
| K151880 | Wingman Crossing Catheter | Reflow Medical | DQY | Class II | 2015-08-07 |
| K151587 | Digital Automatic Wrist Blood Pressure Monitor MD3200 | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2015-08-07 |
| K151623 | Penumbra System 110 Aspiration Tubing | Penumbra, Inc. | NRY | Class II | 2015-08-06 |
| K150095 | ReDs Wearable System | Sensible Medical Innovations , Ltd. | DSB | Class II | 2015-08-06 |
| K150614 | Reveal LINQ | Medtronic, Inc. | MXD | Class II | 2015-08-06 |
| K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | DQX | Class II | 2015-08-03 |
| K150865 | Metacross RX PTA Balloon Dilitation Catheter | KANEKA Corporation | DQY | Class II | 2015-08-03 |
| K143676 | B40i Patient Monitor | GE Healthcare Finland Oy | MHX | Class II | 2015-07-31 |
| K143219 | NIRO-200NX | Hamamatsu Photonics K.K. | MUD | Class II | 2015-07-31 |
| K151363 | Zephyr Vascular Compression Device | Advanced Vascular Dynamics | DXC | Class II | 2015-07-31 |
| K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter | Micro Therapeutics Inc Dba Ev3 Neurovascular | DQY | Class II | 2015-07-29 |
| K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer | Cook Incorporated | DYB | Class II | 2015-07-28 |
| K151187 | QuadraSphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | 2015-07-27 |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | Deltex Medical Limited | DPW | Class II | 2015-07-24 |
| K143193 | Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters | Boston Scientific | LIT | Class II | 2015-07-24 |
| K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | Cook Incorporated | DYB | Class II | 2015-07-24 |
| K140740 | TRANSONIC TISSUE PERFUSION MONITOR | Transonic Systems, Inc. | DPW | Class II | 2015-07-23 |
| K151730 | Magellan Robotic System | Hansen Medical, Inc. | DXX | Class II | 2015-07-23 |
| K143735 | Digital Automatic Blood Pressure Monitor MD2300 | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2015-07-23 |
| K143152 | TM-ABI system | Ld Technology, LLC | JOM | Class II | 2015-07-22 |
| K151676 | Retracta Detachable Embolization Coil | Cook Incorporated | KRD | Class II | 2015-07-22 |
| K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | Sotera Wireless, Inc. | MHX | Class II | 2015-07-20 |
| K151681 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | DSI | Class II | 2015-07-17 |
| K151377 | ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare | Medical Compression System (Dbn) , Ltd. | JOW | Class II | 2015-07-16 |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | Bio Compression Systems, Inc. | JOW | Class II | 2015-07-16 |
| K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | DWF | Class II | 2015-07-16 |
| K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter | St Jude Medical | DRF | Class II | 2015-07-15 |
| K151330 | Microlife Wrist Watch Blood Pressure Monitor | Microlife Intellectual Property GmbH, Switzerland | DXN | Class II | 2015-07-14 |
| K150349 | Rapid Hair Removal Pads | Full Power Aed | LDD | Class II | 2015-07-14 |
| K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | Cardiac Insight, Inc. | DSH | Class II | 2015-07-11 |
| K143202 | ANGIO-PRESS DVT Compression Device Model Name: IPCS | Pegasus Medical Supply, Inc. | JOW | Class II | 2015-07-07 |
| K151317 | Armada 18 PTA Catheter | Abbott Vascular | LIT | Class II | 2015-07-06 |
| K150632 | Hypervisor IX Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MSX | Class II | 2015-07-06 |
| K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | Care Fusion | DWM | Class II | 2015-07-02 |
| K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | DQK | Class II | 2015-07-02 |
| K140762 | AUTOMATIC BLOOD PRESSURE MONITOR | Jawon Medical Co., Ltd. | DXN | Class II | 2015-07-02 |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | DSP | Class II | 2015-07-02 |
| K151497 | EN Snare Endovascular Snare System | Merit Medical Systems, Inc. | MMX | Class II | 2015-07-01 |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | DXX | Class II | 2015-07-01 |
| K151281 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan Ageless Health Industrial Co., Ltd. | DXN | Class II | 2015-06-30 |
| K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | DXQ | Class II | 2015-06-30 |
| K151246 | Aneroid Sphygmomanometer | Jiaxing Zhongfa Medical Products Co., Ltd. | DXQ | Class II | 2015-06-30 |
| K150493 | Sensis | Siemens Medi Cal Solutions, Inc. | DQK | Class II | 2015-06-30 |
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | Asahi Intecc Co., Ltd. | DQX | Class II | 2015-06-30 |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | Natec Medical , Ltd. | LOX | Class II | 2015-06-28 |
| K143449 | ADH 200 Analyzer Software | Adams Meditech, LLC | DQK | Class II | 2015-06-26 |
| K143398 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | DQO | Class II | 2015-06-26 |
| K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2015-06-25 |
| K142357 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | DYB | Class II | 2015-06-25 |
| K143604 | Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters | Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S | DQO | Class II | 2015-06-25 |
| K143093 | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) | Hotspur Technologies, Inc., | LIT | Class II | 2015-06-24 |
| K143438 | Flowtron ACS900 | Getinge (Suzhou) Co., Ltd. | JOW | Class II | 2015-06-23 |
| K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | DQY | Class II | 2015-06-23 |
| DEN140018 | ESOPHAGEAL COOLING DEVICE | Advanced Cooling Therapy, LLC | PLA | Class II | 2015-06-23 |
| K150257 | PreludeEASE Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | 2015-06-19 |
| K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | DSH | Class II | 2015-06-19 |
| K150667 | True Dilatation Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | OZT | Class II | 2015-06-17 |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | DXX | Class II | 2015-06-17 |
| K150512 | STAR 90 | Skanray Technologies Pvt, Ltd. | MWI | Class II | 2015-06-17 |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | DXF | Class II | 2015-06-17 |
| K150303 | XXL Vascular Balloon Dilatation Catheter | Boston Scientific Corp | LIT | Class II | 2015-06-15 |
| K150616 | Trevo XP ProVue Retriever (4x30mm) | Concentric Medical, Inc. | NRY | Class II | 2015-06-12 |
| K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | DQX | Class II | 2015-06-12 |
| K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2015-06-11 |
| K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | PLB | Class II | 2015-06-11 |
| K150489 | EOS PMP, EOS PMP Integrated | Sorin Group Italia S.R.L. | DTZ | Class II | 2015-06-11 |
| K151244 | Pre-Formed Guidewire | Lake Region Medical | DQX | Class II | 2015-06-11 |
| K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD | Cardiovascular System, Inc. | MCW | Class II | 2015-06-10 |
| K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Boston Scientific Limited | PNO | Class II | 2015-06-10 |
| K151082 | MicroCross Catheter | Roxwood Medical, Inc. | DQY | Class II | 2015-06-07 |
| K142503 | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | DSB | Class II | 2015-06-05 |
| K150186 | Chariot Guiding Sheath | Boston Scientific Corp | DYB | Class II | 2015-06-05 |
| K143570 | WIRION | Gardia Medical | NTE | Class II | 2015-06-04 |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter | Natec Medical , Ltd. | LIT | Class II | 2015-06-04 |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 | Shenzhen Creative Industry Co., Ltd. | DQA | Class II | 2015-06-03 |
| K143432 | Cardio-TriTest | Cardio-Phoenix, Inc. | DPS | Class II | 2015-06-03 |
| K142692 | Occlusion Balloon Catheter | Embolx, Inc. | MJN | Class II | 2015-05-31 |
| K150802 | Heavy Double Flexible Tipped Wire Guide | Cook Incorporated | DQX | Class II | 2015-05-28 |
| K142954 | PTA 14 Balloon Dilatation Catheter OTW | Texasmedical Technologies, Inc. | LIT | Class II | 2015-05-28 |
| K151110 | Intersept Filtered Cardiotomy Reservoir | Medtronic, Inc. | DTN | Class II | 2015-05-27 |
| K150117 | Medtronic Patient Asistant | Medtronic, Inc. | DSI | Class II | 2015-05-27 |
| K143304 | Sickbay Clinical Platform | Medical Informatics Corp | MWI | Class II | 2015-05-26 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.