meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
48
Latest Decision
2013-11-15

Clearances · page 48 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K132542 TRANSGATE GUIDE CATHETER Stryker Neurovascular DQY Class II 2013-11-15
K130569 ND NABIL DIB INFUSION CATHETER Translational Research Institute KRA Class II 2013-11-15
K133208 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corp KRD Class II 2013-11-14
K131262 DIGITAL ELECTROCARDIOGRAPHS Sonoscape Company Limited DPS Class II 2013-11-14
K131778 FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT Maquet Cardiovascular, LLC DSY Class II 2013-11-14
K131026 BOSCH BLOOD PRESSURE METER (BP5000 BT) Robert Bosch Healthcare Systems, Inc. DXN Class II 2013-11-14
K133265 QUADROX-IR ADULT AND SMALL ADULT Maquet Cardiopulmonary, AG KFM Class II 2013-11-12
K132545 MEDIVALVE ACWIRE Medivalve , Ltd. DQX Class II 2013-11-08
K132155 Merit ASAPLP Aspiration Catheter Merit Medical Systems, Inc. QEZ Class II 2013-11-07
K132048 BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET Molnlycke Health Care Us, LLC DWJ Class II 2013-11-06
K132022 LEMAITRE 8F OCCLUSION CATHETER LeMaitre Vascular, Inc. MJN Class II 2013-11-06
K122400 CARDIOX FLOW DETECTION SYSTEM Cardiox Corp. DXG Class II 2013-11-05
K132047 LEMILLS VALVULOTOME LeMaitre Vascular, Inc. MGZ Class II 2013-11-05
K131420 PETITE BASIC SYSTEM 701 ELT Mego Afek AC , Ltd. JOW Class II 2013-11-01
K130649 SILK ROAD ACCESS CATHETER Silk Road Medical, Inc. DQY Class II 2013-11-01
K132995 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO Medtronic, Inc. DWF Class II 2013-10-31
K132924 MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) Medtronic, Inc. DTE Class II 2013-10-31
K130827 FIRMAP CATHETER Topera, Inc. MTD Class II 2013-10-31
K131914 OFFROAD RE-ENTRY CATHETER SYSTEM Boston Scientific Corp PDU Class II 2013-10-31
K132166 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT Maquet Cardiopulmonary, AG DTN Class II 2013-10-30
K131190 MYPATCH Dms-Service, LLC DSH Class II 2013-10-29
K132972 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE Medtronic, Inc. DTN Class II 2013-10-28
K132651 ITCLAMP 50 Innovative Trauma Care, Inc. DXC Class II 2013-10-28
K132083 AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 MicroVention, Inc. KRD Class II 2013-10-28
K131446 INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES Integra LifeSciences Corporation DQR Class II 2013-10-28
K130904 TRELLIS-8 PERIPHERAL INFUSION SYSTEM Covidien QEY Class II 2013-10-25
K132020 ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER Cook, Inc. LIT Class II 2013-10-25
K123696 MEDUSA VASCULAR PLUG Endoshape, Inc. KRD Class II 2013-10-25
K132556 SHEATHLESS EAUCATH CORONARY GUIDE CATHETER Asahi Intecc Co., Ltd. DQY Class II 2013-10-24
K130971 OPTUM TELEHEALTH APPLICATION Optumhealth Care Solutions, Inc. DRG Class II 2013-10-23
K132627 AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Honsun (Nantong) Co., Ltd. DXN Class II 2013-10-23
K132990 OCCLUSION BALLOON CATHETER Boston Scientific Corp MJN Class II 2013-10-22
K132673 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER Medtronic, Inc. DQY Class II 2013-10-22
K130684 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems MKJ Class III 2013-10-18
K132947 DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS Boston Scientific Corp KRA Class II 2013-10-18
K130719 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc. OGZ Class II 2013-10-17
K132430 STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 2013-10-17
K130378 RESPIGUIDE DELIVERY SYSTEM Respicardia DQY Class II 2013-10-17
K130942 LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF Legacy Medical, Inc. DXQ Class II 2013-10-17
K131872 INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2013-10-17
K124041 NBM-200MP Orsense, Ltd. DQA Class II 2013-10-17
K131047 FINGERTIP PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2013-10-16
K130294 BRAEMAR CARDIOKEY HOLTER RECORDER Braemar Manufacturing, LLC MWJ Class II 2013-10-16
K132405 PPA/BT-RB STETHOSCOPE Rnk Products, Inc. DQD Class II 2013-10-11
K132560 PCP-USB STETHOSCOPE Rnk Products, Inc. DQD Class II 2013-10-11
K130660 AUDICOR CPAM WITH SDB (SINGLE SENSOR) Inovise Medical, Inc. MLO Class II 2013-10-11
K131437 MODIFIED CONCENTRIC MICROCATHETER Concentric Medical, Inc. DQO Class II 2013-10-11
K130858 REVERSE MEDICAL MICROCATHETER Reverse Medical Corporation DQY Class II 2013-10-11
K132139 DELTEX MEDICAL CARDIOQ-EDM+ Deltex Medical Limited DPW Class II 2013-10-10
K132829 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS Maquet Cardiopulmonary, AG DTZ Class II 2013-10-08
K131749 HEM-6221 Omron Healthcare, Inc. DXN Class II 2013-10-07
K130709 VISI MOBILE MONITORING SYSTEM Sotera Wireless, Inc. MWI Class II 2013-10-07
K132454 VITAHEAT PATIENT WARMING SYSTEM Vitaheat Medical, LLC DWJ Class II 2013-10-04
K132675 EMBOZENE MICROSPHERES Celonova Biosciences, Inc. KRD Class II 2013-10-03
K131492 MODIFIED FLOWGATE BALLOON GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2013-10-03
K130525 OCCLUSION PERFUSION CATHETER Advanced Catheter Therapies, Inc. DQY Class II 2013-10-03
K130947 FINGERTIP PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2013-10-03
K123711 PATIENT MONITOR Shenzhen Creative Industry Co., Ltd. MWI Class II 2013-10-01
K132696 TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR GE Healthcare Finland Oy DQA Class II 2013-09-27
K131860 VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING Us Vascular, LLC JOP Class II 2013-09-27
K132713 NMI COAXIAL MICROINTRODUCER SET Navilyst Medical, Inc. DRE Class II 2013-09-27
K132030 MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING Medtronic, Inc. DYB Class II 2013-09-27
K132659 VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM Volcano Corporation DQY Class II 2013-09-27
K131618 LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST Terumo Cardiovascular Systems Corporation DWB Class II 2013-09-27
K132369 MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR Hansen Medical, Inc. DXX Class II 2013-09-27
K132777 NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER Ev3, Inc. LIT Class II 2013-09-26
K131411 COSEAL Jilin Coronado Medical , Ltd. DXC Class II 2013-09-26
K130952 PRECISION ONE LIFECARE; DETECTO; DETECTO Precision One Lifecare, Ltd. MNW Class II 2013-09-26
K132068 PHILIPS DXL 12/16-LEAD ECG ALGORITHM Philips Medical Systems DPS Class II 2013-09-26
K132701 PRIMI SUPPORT CATHETER Thermopeutix, Inc. DQY Class II 2013-09-26
K132133 CG+ ARROW JACC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) OBJ Class II 2013-09-26
K132420 WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical DQY Class II 2013-09-19
K131394 TRANSTEK GLASS BODY FAT ANALYZER Guangdong Transtek Medical Electronics Co., Ltd. MNW Class II 2013-09-18
K130232 ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM Jinxinbao Electronic Co.,Ltd DXN Class II 2013-09-17
K132164 HEARTSPAN STEERABLE INTRODUCER KIT Merit Medical Systems, Inc. DYB Class II 2013-09-17
K123130 ANSWATCH WRIST MONITOR MODEL TS-0411 Taiwan Scientific Corporation DXN Class II 2013-09-17
K131494 HEART SYNC Heart Sync, Inc. MKJ Class III 2013-09-16
K131854 CEROX Or-Nim Medical , Ltd. DPW Class II 2013-09-13
K132175 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER Edwards Lifesciences, LLC DXC Class II 2013-09-13
K132578 INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corp KRD Class II 2013-09-13
K130925 AUTOMATIC BLOOD PRESSURE MONITOR Honsun (Nantong) Co., Ltd. DXN Class II 2013-09-12
K131021 PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2013-09-11
K131111 IHEALTH FINGERTIP PULSE OXIMETER Andon Health Co, Ltd. DQA Class II 2013-09-11
K132073 EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE St Jude Medical DQK Class II 2013-09-09
K130409 ALIVECOR HEART MONITOR AliveCor, Inc. DPS Class II 2013-09-06
K131452 PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 St. Jude Medical Systems AB DXO Class II 2013-09-05
K131148 THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH Access Scientific, LLC DYB Class II 2013-09-04
K131044 SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION Diacoustic Medical Devices (Pty) , Ltd. DQD Class II 2013-09-04
K131064 BIOSPACE Biospace Corporation Limited DXN Class II 2013-09-04
K123792 HORIZON XVU (FFR) Mennen Medical , Ltd. DQX Class II 2013-08-30
K132359 MRI PATIENT MONITORING SYSTEM Invivo Corporation MWI Class II 2013-08-30
K131818 VITAL SIGNS MONITOR Edan Instruments, Inc. DQA Class II 2013-08-30
K131558 PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 Shenzhen Pango Electronic Co., Ltd. DXN Class II 2013-08-30
K132281 ReVive PV (Peripheral Vasculature) Thrombectomy Device Codman & Shurtleff, Inc. QEW Class II 2013-08-30
K132409 CONCIERGE GUIDING CATHETER Merit Medical Systems, Inc. DQY Class II 2013-08-29
K130727 ENSITE VELOCITY SYSTEM St Jude Medical DQK Class II 2013-08-29
K131048 LIDCO CNAP MODULE Lidco, Ltd. DXG Class II 2013-08-28
K131223 CARESCAPE MONITOR B650 GE Healthcare Finland Oy MHX Class II 2013-08-28
K131414 CARESCAPE MONITOR B850 GE Healthcare Finland Oy MHX Class II 2013-08-28
K131124 COLIGN Jilin Coronado Medical , Ltd. DTL Class II 2013-08-28

19,212 clearances in the Cardiovascular panel. Data: openFDA.