Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 40
- Latest Decision
- 2015-05-26
Clearances · page 42 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | QEW | Class II | 2015-05-26 |
| K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | Volcano Atheromed, Inc. | MCW | Class II | 2015-05-26 |
| K151076 | MicroTaper Needle Introducer Set | Summit Access, LLC | DRE | Class II | 2015-05-22 |
| K142458 | Penumbra System ACE | Penumbra, Inc. | NRY | Class II | 2015-05-22 |
| K143436 | InvisionECG System | Invisionheart, Inc. | DPS | Class II | 2015-05-21 |
| K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Company | PDU | Class II | 2015-05-19 |
| K143561 | ELM PTA Balloon Dilatation Catheter | O'Connell Regulatory Consultants, Inc. | LIT | Class II | 2015-05-19 |
| K143728 | Minhua Disposable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus | DXQ | Class II | 2015-05-15 |
| K150691 | Datalys Multi-Parameter Patient Monitor | Lutech Industries, Inc. | MWI | Class II | 2015-05-15 |
| K143078 | Bookwalter Gordon Adjustable Compression Element | Symmetry Surgical | DXC | Class II | 2015-05-14 |
| K150310 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | DSI | Class II | 2015-05-13 |
| K150970 | Coda LP Balloon Catheter | Cook Incorporated | DQY | Class II | 2015-05-12 |
| K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | DTW | Class II | 2015-05-08 |
| K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm | Ostial Corporation | LIT | Class II | 2015-05-08 |
| K150620 | 740 SELECT | Cas Medical Systems, Inc. | MWI | Class II | 2015-05-08 |
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | Maquet Cardiopulmonary, AG | DTZ | Class II | 2015-05-07 |
| K142032 | MRI PATIENT MONITORING SYSTEM TESLA M3 | Mipm Mammendorfer Institut Fur Physik Und Medizin | MWI | Class II | 2015-05-07 |
| K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | JOW | Class II | 2015-05-07 |
| K150389 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | DSY | Class II | 2015-05-06 |
| K150536 | Terumo Circuit Tubing | Terumo Cardiovascular Systems Corporation | DWF | Class II | 2015-05-05 |
| K143714 | Powerheart G5 AED | Cardiac Science Corporation | MKJ | Class III | 2015-05-04 |
| K143608 | NovaCross Microcatheter | Nitiloop , Ltd. | DQY | Class II | 2015-05-04 |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | Bio-Detek, Inc. | MKJ | Class III | 2015-05-02 |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | Bio-Detek, Inc. | MKJ | Class III | 2015-05-02 |
| K143734 | Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2015-05-02 |
| K142087 | COVA MONITORING SYSTEM | Tosense, Inc. | MWI | Class II | 2015-05-01 |
| K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | DWE | Class II | 2015-05-01 |
| K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | MWI | Class II | 2015-04-30 |
| K151013 | Vitaphone Tele ECG Loop Recorder | Vitasystems GmbH | DXH | Class II | 2015-04-30 |
| K150813 | iTClamp50 | Innovative Trauma Care, Inc. | DXC | Class II | 2015-04-30 |
| K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | PDU | Class II | 2015-04-29 |
| K141984 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Andon Health Co, Ltd. | DXN | Class II | 2015-04-29 |
| K143252 | Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) | Needle Tech Products, Inc. | DQX | Class II | 2015-04-23 |
| K141362 | PULSE OXIMETER CMS50EW | Contec Medical Systems Co.,Ltd | DQA | Class II | 2015-04-23 |
| K142817 | IntraNovo 25 Microcatheter | Texasmedical Technologies, Inc. | DQO | Class II | 2015-04-23 |
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels | Boston Scientific Corporation | DRQ | Class II | 2015-04-22 |
| K150108 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | KRD | Class II | 2015-04-22 |
| K143341 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2015-04-21 |
| K142083 | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | C.R. Bard, Inc. | OZT | Class II | 2015-04-17 |
| K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | Fudakang Industrial Co., Ltd. | DXN | Class II | 2015-04-17 |
| K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | Rex Medical, L.P. | DTK | Class II | 2015-04-16 |
| K142551 | QANS (Quantitative Autonomic Nervous System) Monitoring System | Hhssystems, LLC | DPS | Class II | 2015-04-16 |
| K143332 | Fast Sphyg by Koven | Koven Technology, Inc. | DXQ | Class II | 2015-04-14 |
| K143744 | MicroCross Catheter | Roxwood Medical, Inc. | DQY | Class II | 2015-04-14 |
| K142445 | PINPOINT GT SAFETY INTRODUCER NEEDLE | C.R. Bard, Inc. | DYB | Class II | 2015-04-13 |
| K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | MCW | Class II | 2015-04-13 |
| K142687 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | DQA | Class II | 2015-04-13 |
| K140360 | HEALTH KIOSK | Engagementhealth, LLC | DXN | Class II | 2015-04-10 |
| K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | MUD | Class II | 2015-04-10 |
| K150567 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | Medtronic, Inc. | DWF | Class II | 2015-04-09 |
| K150292 | Chocolate PTCA Balloon Catheter | Trireme Medical, LLC | LOX | Class II | 2015-04-09 |
| K143255 | Prelude SNAP Splittable Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | 2015-04-09 |
| K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | PNO | Class II | 2015-04-08 |
| K143077 | Trevo XP ProVue Retriever (6X25mm) | Concentric Medical, Inc. | NRY | Class II | 2015-04-06 |
| K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | OZT | Class II | 2015-04-03 |
| K150262 | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular | Volcano Corporation | DTK | Class II | 2015-04-03 |
| K143733 | Digital Automatic Wrist Blood Pressure Monitor MD2400 | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2015-04-03 |
| K141683 | ELECTRONIC BLOOD PRESSURE MONITOR | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | 2015-04-03 |
| K143372 | AWARE | Ambient Clinical Analytics | MWI | Class II | 2015-04-02 |
| K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic, Inc. | LOX | Class II | 2015-04-02 |
| K150227 | Disposable Blood Pressure Cuff Guard | Pinhu Sama Medical Packing Co., Ltd. | DXQ | Class II | 2015-04-02 |
| K150545 | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) | Sejoy Electronics & Instruments Co., Ltd. | DXN | Class II | 2015-04-02 |
| K142745 | 125mL CT Syringe | Coeur, Inc. | DXT | Class II | 2015-04-01 |
| K143459 | Silk Road Acccess Catheter | Silk Road Medical, Inc. | DQY | Class II | 2015-04-01 |
| K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter | St Jude Medical | DRF | Class II | 2015-04-01 |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | Natec Medical , Ltd. | LIT | Class II | 2015-03-30 |
| K143032 | eMotion Faros ECG Mobile | Mega Electronics , Ltd. | DXH | Class II | 2015-03-29 |
| K143108 | HealthGuard-15 | Futrex, Inc. | DXN | Class II | 2015-03-27 |
| K150366 | SOFIA 6F Catheter | MicroVention, Inc. | DQY | Class II | 2015-03-27 |
| K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | MKJ | Class III | 2015-03-27 |
| K141322 | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER | Cook Incorporated | PNO | Class II | 2015-03-27 |
| K142449 | Headway 27 Microcatheter | MicroVention, Inc. | DQY | Class II | 2015-03-26 |
| K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | DXT | Class II | 2015-03-26 |
| K142865 | Nellcor Bedside SpO2 Patient Monitoring System | Covidien, LLC | DQA | Class II | 2015-03-26 |
| K143073 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface | Medtronic, Inc. | DTZ | Class II | 2015-03-25 |
| K143083 | Bio-Medicus Pediatric Cannula and Introducers | Medtronic, Inc. | DWF | Class II | 2015-03-25 |
| K140356 | SUMMED HIGH PRESSURE LINE | Sunny Medical Device (Shenzhen) Co., Ltd. | DQO | Class II | 2015-03-20 |
| K141460 | FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR | Finapres Medical Systems B.V. | DXN | Class II | 2015-03-20 |
| K150422 | EOPA 3D Arterial Cannula | Medtronic, Inc. | DWF | Class II | 2015-03-20 |
| K142959 | Vyntus Walk | Carefusion Germany 234 GmbH | DQA | Class II | 2015-03-20 |
| K143463 | IS4/DF4 Port Plug | Oscor, Inc. | DTD | Class II | 2015-03-19 |
| K143503 | BioMonitor | Biotronik, Inc. | MXD | Class II | 2015-03-19 |
| K143216 | Assurance Alar / Nasal SpO2 Sensor | Xhale, Inc. | DQA | Class II | 2015-03-17 |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | MHX | Class II | 2015-03-16 |
| K142352 | CardiacLinx | Ross Medical Technology, Inc. | DSI | Class II | 2015-03-12 |
| K143316 | Attain Hybrid Guide Wire | Medtronic, Inc. | DQX | Class II | 2015-03-11 |
| K141981 | ASAHI FUBUKI 043 / ASAHI FUBUKI | Asahi Intecc Co., Ltd. | DQY | Class II | 2015-03-09 |
| K143160 | FOXTROT NC PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | LOX | Class II | 2015-03-05 |
| K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Covidien | DQA | Class II | 2015-03-05 |
| K140943 | MASTRO PLUS BALLOON IN-DEFLATION DEVICE | Beijing Demax Medical Technology Co.,Ltd | MAV | Class II | 2015-03-05 |
| K143094 | QuantaFlo | Semler Scientific, Inc. | JOM | Class II | 2015-03-05 |
| K142732 | T3 Software | Etiometry, Inc. | MWI | Class II | 2015-03-04 |
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Angioscore, Inc. | PNO | Class II | 2015-03-04 |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Spectranetics, Inc. | DRE | Class II | 2015-03-04 |
| K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter | Spectranetics, Inc. | DQY | Class II | 2015-02-27 |
| K143652 | Vector PTA Balloon Dilatation Catheter | Vector Corporation, LLC | LIT | Class II | 2015-02-26 |
| K142693 | ZywieAI Software Library | Zywie, Inc. | DPS | Class II | 2015-02-20 |
| K143135 | Spring Coil Guidewire | Neometrics, Inc. | DQX | Class II | 2015-02-20 |
| K142888 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | 2015-02-20 |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | 2015-02-18 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.