meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
48
Latest Decision
2007-01-19

Clearances · page 76 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K062868 THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 Flowcardia, Inc. DQY Class II 2007-01-19
K063561 MOORLDLS LASER DOPPLER LINE SCANNER Moor Instruments, Ltd. DPT Class II 2007-01-19
K063785 SPIDERFX EMBOLIC PROTECTION DEVICE Ev3, Inc. NFA Class II 2007-01-19
K062027 A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 2007-01-19
K063372 RADIFOCUS GLIDEWIRE ADVANTAGE Terumo Medical Corp. DQX Class II 2007-01-19
K062877 TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 Vascular Solutions, Inc. DQO Class II 2007-01-18
K061678 PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 Prorhythm DRF Class II 2007-01-12
K063217 VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) B.Braun Medical, Inc. DTK Class II 2007-01-12
K063255 D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED Sorin Group Italia S.R.L. DTM Class II 2007-01-11
K063375 HEARTSTART MRX, MODELS M3535A OR M3536A Philips Medical Systems MKJ Class III 2007-01-11
K063405 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM Radiant Medical NCX Class II 2007-01-08
K062627 INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 Vascular Solutions, Inc. DQO Class II 2007-01-05
K063525 DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM Datascope Corp. DSP Class II 2007-01-05
K063140 RAINBOW ADHESIVE CO-OXIMETRY SENSORS Masimo Corporation DQA Class II 2006-12-29
K063612 MODIFICATION TO HEALTH BUDDY APPLIANCE Health Hero Network, Inc. DRG Class II 2006-12-29
K062652 INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR Tanita Corporation of America MNW Class II 2006-12-28
K062265 CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM Swiss Medical Care S.A. IZQ Class II 2006-12-26
K063119 LIFEPAK 20 DEFIBRILLATOR/ MONITOR Medtronic Emergency Response Systems, Inc. MKJ Class III 2006-12-22
K063484 PATIENT DATA HANDLER & DEVICES (PDH&D) Intermed Advisors, Inc. DRG Class II 2006-12-22
K063602 AUTOPULSE RESUSCITATION SYSTEM MODEL100 Zoll Circulation DRM Class II 2006-12-21
K063055 VS-800 VITAL SIGNS MONITOR Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MWI Class II 2006-12-21
K063547 CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM Witt Biomedical Corp MWI Class II 2006-12-21
K063182 ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX Enpath Medical, Inc. DYB Class II 2006-12-21
K063619 FLIPPER DETACHABLE EMBOLIZATION COILS Cook, Inc. KRD Class II 2006-12-20
K062577 V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC Tz Medical, Inc. DSA Class II 2006-12-15
K061680 ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER Atrium Medical Corp. DQY Class II 2006-12-15
K063371 PRONTO V3 EXTRACTION CATHETER, MODEL 5003 Vascular Solutions, Inc. QEZ Class II 2006-12-14
K062582 SUPRACOR BALLOON CATHETER Abiomed, Inc. DSP Class II 2006-12-14
K062177 ZOLL E SERIES WITH REAL CPR HELP ZOLL Medical Corporation MKJ Class III 2006-12-13
K052465 REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 Heartsine Technologies, Inc. MKJ Class III 2006-12-12
K063657 VASCUTRAK PTA DILATION CATHETER Ymed, Inc. PNO Class II 2006-12-12
K063087 MODIFICATION TO MODEL 750 SERIES MONITOR Cas Medical Systems, Inc. MWI Class II 2006-12-11
K062760 ORI F6T DRY ECG MONITORING ELECTRODE Orbital Research, Inc. DRX Class II 2006-12-11
K061902 COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 Inditherm Medical DWJ Class II 2006-12-08
K061484 MODIFICATION TO: SMITHWICK CAROTID SHUNT Mcpherson Enterprises, Inc. DXC Class II 2006-12-07
K062794 PRN THERMALCARE, MODEL 3000 American Healthcare Products, Inc. DWJ Class II 2006-12-07
K062752 MERCATOR MICROSYRINGE II INFUSION CATHETER Mercator Medsystems, Inc. KRA Class II 2006-12-07
K062364 I-SCOPE 200 Dongjin Medical Co., Ltd. DQD Class II 2006-12-06
K062324 MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN GE Healthcare MHX Class II 2006-12-06
K051817 BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM Cardiva Medical, Inc. DXC Class II 2006-12-06
K062508 NEUROWAVE MICRO-INFUSION SYSTEM Ekos Corp. NUI Class II 2006-12-05
K063313 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) Boston Scientific Corp NTE Class II 2006-12-05
K062769 PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 Radi Medical Systems AB DXO Class II 2006-12-04
K063419 MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) Welch Allyn Protocol, Inc. MWI Class II 2006-12-04
K063312 MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 Boston Scientific Corp DQO Class II 2006-11-30
K063277 MAPMATE Ep Medsystems, Inc. DQK Class II 2006-11-30
K062271 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) Philips Medical Systems MHX Class II 2006-11-30
K061814 VASOPRESS DVT SYSTEM, MODEL VP500D Compression Therapy Concepts, Inc. JOW Class II 2006-11-30
K062233 HEARTSTART MRX MONITOR/DEFIBRILLATOR Philips Medical Systems North America, Inc. MKJ Class III 2006-11-22
K061951 ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 Possis Medical, Inc. QEZ Class II 2006-11-22
K062507 MICRO-INFUSION SYSTEM Ekos Corp. QEY Class II 2006-11-22
K062662 TELEMEDICINE SYSTEM MODEL VMS-01 Medic4all (Israel) , Ltd. DRG Class II 2006-11-21
K063315 INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 Philips Medizin Systeme Boeblingen GmbH MHX Class II 2006-11-20
K061601 ASAHI PRECIOUS GUIDE CATHETER Asahi Intecc Co., Ltd. DQY Class II 2006-11-17
K062677 ELI 350 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2006-11-15
K053420 TENACORE SP02 SENSORS Tenacore Holdings, Inc. DQA Class II 2006-11-15
K063204 SPIDERFX EMBOLIC PROTECTION DEVICE Ev3, Inc. NTE Class II 2006-11-14
K063252 ATB ADVANCED PTA DILATATION CATHETER Cook, Inc. DQY Class II 2006-11-14
K063222 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 Cardionet, Inc. QYX Class II 2006-11-14
K062186 ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J Asahi Intecc Co., Ltd. DQX Class II 2006-11-09
K062474 SMITHWICK CAROTID SHUNT Mcpherson Enterprises, Inc. DXC Class II 2006-11-09
K062605 PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T Philips Medical Systems DQA Class II 2006-11-09
K062161 GORE PROPATEN VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 2006-11-09
K062127 MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) Medic4all (Israel) , Ltd. DRG Class II 2006-11-08
K061935 SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR Sensacare , Ltd. DXN Class II 2006-11-08
K061848 HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 Hypermed, Inc. MUD Class II 2006-11-08
K061905 HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 Medcon , Ltd. DQK Class II 2006-11-08
K062043 BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 Omron Healthcare, Inc. MNW Class II 2006-11-07
K052742 HEPASPHERE MICROSPHERES Biosphere Medical, Inc. KRD Class II 2006-11-07
K062999 OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN Hospira, Inc. DQE Class II 2006-11-03
K062469 VOYAGER 12 Del Mar Reynolds Medical, Ltd. DPS Class II 2006-11-03
K061993 EQUIVITAL, MODEL EQ-01 Hidalgo Limited MHX Class II 2006-11-03
K062455 PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL Philips Medical Systems DQA Class II 2006-11-03
K062597 TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA Terumo Cardiovascular Systems Corp. DWF Class II 2006-11-03
K060756 MEDLOG, MODEL 1-0-10 Bmc Gesellschaft Fur Medizintechnik Mbh MWI Class II 2006-10-30
K063113 EP-WORKMATE Ep Medsystems DQK Class II 2006-10-27
K062068 INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 Intelwave, LLC DPS Class II 2006-10-27
K062887 MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F Bard Peripheral Vascular DTK Class II 2006-10-26
K061416 SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 Medtronic Vascular DQY Class II 2006-10-25
K052944 AMBU WHITE SENSOR CFM, CFL Ambu A/S DRX Class II 2006-10-25
K062338 TELEVISIT PHD Medical DQA Class II 2006-10-25
K053550 AMBU BLUE SENSOR NEO AND NEO X Ambu A/S DRX Class II 2006-10-25
K061188 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Foxhollow Technologies, Inc. MCW Class II 2006-10-23
K062446 MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH Terumo Medical Corp. DYB Class II 2006-10-23
K062251 REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 St Jude Medical DRF Class II 2006-10-20
K062858 MODIFICATION TO GLIDESHEATH Terumo Medical Corp. DYB Class II 2006-10-20
K062870 TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 Kensey Nash Corp. NFA Class II 2006-10-20
K062202 OCCLUSION BALLOON Boston Scientific Corp DQY Class II 2006-10-20
K060967 NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION Stereotaxis, Inc. NDQ Class II 2006-10-19
K062268 MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 Philips Medical Systems North America Co. DQA Class II 2006-10-18
K062809 ADMIRAL XTREME PTA CATHETER Invatec Innovative Technologies DQY Class II 2006-10-18
K062843 FOX SV PTA CATHETER Abbott Laboratories LIT Class II 2006-10-17
K062481 SERENO ELECTRONIC STETHOSCOPE Pishon High Tech Co., Ltd. DQD Class II 2006-10-16
K061428 PMP4 APPLICATION Card Guard Scientific Survival , Ltd. MSX Class II 2006-10-16
K062215 CONFIDANT 2.0 Confidant, Inc. DRG Class II 2006-10-16
K062959 DMS 300-2, 300-3 AND 300-4 Diagnostic Monitoring Software MWJ Class II 2006-10-16
K061070 HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR Hansen Medical, Inc. DRC Class II 2006-10-13
K061046 CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 Cardiomems, Inc. NQH Class II 2006-10-12
K062144 ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 Invivo Corporation MHX Class II 2006-10-12
K060538 BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 Beaverite International Limited MNW Class II 2006-10-10

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