meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2009-02-27

Clearances · page 68 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K083395 SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 Andon Health Co, Ltd. DXN Class II 2009-02-27
K083732 TAD AND TAD II TAPERED GUIDE WIRES Abbott Vascular DQX Class II 2009-02-25
K083683 ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC Genesee Biomedical, Inc. KRH Class II 2009-02-25
K082583 INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2009-02-25
K083229 E.S TECK ( ELECTRO SENSOR TECK) Ld Technology, LLC MWI Class II 2009-02-23
K083713 .035 LOC GUIDE WIRE EXTENSION Abbott Vascular DQX Class II 2009-02-23
K083727 STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 Bridgepoint Medical DQX Class II 2009-02-20
K090212 MAC 800 RESTING ECG ANALYSIS SYSTEM Ge Medical Syst. Information Technologies DPS Class II 2009-02-19
K090276 ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. DQO Class II 2009-02-19
K082124 CARDITTE MICROTEL Et Medical Devices Spa DPS Class II 2009-02-19
K082117 QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 Maquet Cardiopulmonary, AG DTZ Class II 2009-02-18
K083735 ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS Medtechs, LLC JOM Class II 2009-02-18
K083855 MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 Acumen Medical, Inc. DYB Class II 2009-02-17
K083639 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE Ge Medical Systems Information Technologies DQK Class II 2009-02-17
K083854 CARDIAC TRIGGER, MODEL: CTM300 Ivy Biomedical Systems, Inc. DRT Class II 2009-02-13
K082930 CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE Cardiva Medical, Inc. DXC Class II 2009-02-13
K083309 ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 Zargis Medical Corp. DQD Class II 2009-02-13
K082321 TERUMO ROCSAFE HYBRID PERFUSION SYSTEM Terumo Cardiovascular Systems Corp. KFM Class II 2009-02-13
K090085 MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 Concentric Medical, Inc. NRY Class II 2009-02-12
K083828 SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT Transoma MXC Class II 2009-02-11
K081560 VASCUTEK CANNULA GRAFT, MODEL CGS2008S Vascutek, Ltd. DWF Class II 2009-02-10
K080987 BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES Bridgepoint Medical DQY Class II 2009-02-06
K082873 MEDTRONIC ANGIOGRAPHIC GUIDE WIRES Medtronic Vascular DQX Class II 2009-02-06
K083706 HI-TORQUE VERSACORE GUIDE WIRE Abbott Vascular DQX Class II 2009-02-06
K082268 CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX Oridion Capnography, Inc. DQA Class II 2009-02-06
K090040 RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) Terumo Medical Corp. DQO Class II 2009-02-06
K081927 RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO Renu Medical, Inc. NLF Class II 2009-02-06
K083422 6F TAIGA GUIDING CATHETER Medtronic Vascular DQY Class II 2009-02-06
K083523 MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc. DXT Class II 2009-02-04
K081947 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING Gish Biomedical, Inc. DTN Class II 2009-02-04
K083300 GORE FLOW REVERSAL SYSTEM W. L. Gore & Associates, Inc. NTE Class II 2009-02-04
K082082 GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING Gish Biomedical, Inc. DTN Class II 2009-02-04
K083127 ASAHI CORSAIR MICROCATHETER Asahi Intecc Co., Ltd. DQY Class II 2009-02-03
K083269 CROSSOVER Thomas Medical Products, Inc. DYB Class II 2009-02-03
K081576 BLAZER DX-20 DIAGNOSTIC CATHETER Boston Scientific Corp DRF Class II 2009-02-03
K083287 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM Corventis, Inc. DSI Class II 2009-02-03
K090027 BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 Zen Strong Medical Technology Co., Ltd. DXN Class II 2009-02-02
K083313 WILDCAT 7F GUIDEWIRE SUPPORT CATHETER Avinger, Inc. DQY Class II 2009-02-02
K080708 VISION HOLLOW FIBER OXYGENATOR WITH HA COATING Gish Biomedical, Inc. DTZ Class II 2009-02-02
K083319 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 Andon Health Co, Ltd. DXN Class II 2009-01-29
K083247 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 Andon Health Co, Ltd. DXN Class II 2009-01-29
K083246 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 Andon Health Co, Ltd. DXN Class II 2009-01-29
K083904 ASAHI SUOH PTCA GUIDE WIRE Asahi Intecc Co., Ltd. DQX Class II 2009-01-29
K083248 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 Andon Health Co, Ltd. DXN Class II 2009-01-29
K083318 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 Andon Health Co, Ltd. DXN Class II 2009-01-29
K083317 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 Andon Health Co, Ltd. DXN Class II 2009-01-29
K073593 I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 Deltex Medical Limited DPT Class II 2009-01-29
K081846 GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 Vascular Solutions, Inc. DQO Class II 2009-01-28
K081878 LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM LeMaitre Vascular, Inc. DQY Class II 2009-01-27
K081838 GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING Gish Biomedical, Inc. DTR Class II 2009-01-26
K083489 JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 Pathway Medical Technologies, Inc. MCW Class II 2009-01-23
K081881 GISH TUBING AND CONNECTORS WITH HA COATING Gish Biomedical, Inc. DWF Class II 2009-01-23
K083470 CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 Edwards Lifesciences, LLC KRH Class II 2009-01-23
K083835 ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR St Jude Medical KRH Class II 2009-01-23
K082212 SYRINGE WITH HANDI-FIL Mallinckrodt Inc., Liebel-Flarsheim Business DXT Class II 2009-01-22
K081499 HEALTH MANAGER, VERSION 1.1 Biocomfort Diagnostics GmbH & Co. KG DRG Class II 2009-01-16
K082626 PAM 3000 Wireless 2000 RF & Uwb Technologies , Ltd. DRT Class II 2009-01-16
K083517 INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN DSI Class II 2009-01-16
K082887 PM-1000F+PATIENT MONITOR Advanced Instrumentations, Inc. MWI Class II 2009-01-16
K083046 FORA TELEHEALTH SYSTEM Taidoc Technology Corporation DRG Class II 2009-01-16
K083681 BIOLAND BLOOD PRESSURE MONITOR Bioland Technology, Ltd. DXN Class II 2009-01-16
K082337 MINNIE SUPPORT CATHETER Vascular Solutions, Inc. DQY Class II 2009-01-15
K081054 GISH ARTERIAL FILTER WITH HA COATING Gish Biomedical, Inc. DTM Class II 2009-01-15
K081033 MIROXI Mir Medical Intl. Research Srl DQA Class II 2009-01-15
K090004 LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES Levitronix, LLC DWA Class II 2009-01-15
K083814 OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 Cordis Corp., A Johnson & Johnson Co. PDU Class II 2009-01-13
K083837 JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) Pathway Medical Technologies, Inc. MCW Class II 2009-01-13
K082905 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC Medrad, Inc. DXT Class II 2009-01-12
K083145 ASAHI GUIDE WIRE EXTENSION, MODEL AG149000 Asahi Intecc Co., Ltd. DQX Class II 2009-01-12
K082787 VITAL SIGNS MONITOR, MODEL: MD500B Beijing Choice Electronic Technololgy Co., Ltd. MWI Class II 2009-01-12
K082746 ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 Insightra Medical, Inc. DSP Class II 2009-01-12
K083331 CONFIDANT, MODEL 2.6 Confidant, Inc. DRG Class II 2009-01-09
K082789 G1B PULSE OXIMETER General Meditech, Inc. DQA Class II 2009-01-07
K080179 REFLEXION HD HIGH-DENSITY MAPPING CATHETER St Jude Medical DRF Class II 2009-01-07
K081924 CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE Calhealth, Inc. DXN Class II 2009-01-07
K081258 VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 Biosense Webster, Inc. DRF Class II 2009-01-06
K082613 MERIT MICROCATHETER Merit Medical Systems, Inc. KRA Class II 2008-12-30
K082946 MORTARA ELI 350 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2008-12-29
K082709 VICOR PD2I ANALYZER, VERSION 2.1 Vicor Technologies, Inc. DPS Class II 2008-12-29
K083347 IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS Fluke Biomedical DRL Class II 2008-12-24
K083657 CONQUEST PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. DQY Class II 2008-12-24
K083271 BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY Nihon Kohden America, Inc. MHX Class II 2008-12-24
K083091 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES Biocompatibles UK Limited KRD Class II 2008-12-24
K081768 COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES Cook Incorporated NAJ Class II 2008-12-23
K082630 VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES Zefon Intl. DXQ Class II 2008-12-19
K083301 X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS Terumo Cardiovascular Systems Corp. DWF Class II 2008-12-18
K082344 STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) Sorin Group Deutschland GmbH DWF Class II 2008-12-17
K082421 HEARTSUITE HEMODYNAMICS 7.10 Emageon, Inc. DQK Class II 2008-12-17
K082094 BARD PTFE (TEFLON) COATED GUIDE WIRES C.R. Bard Inc., Bard Electrophysiology Division DQX Class II 2008-12-17
K081498 TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 Biocomfort Diagnostics GmbH & Co. KG DXN Class II 2008-12-17
K083535 HEARTRAK SMART ECAT Universal Medical, Inc. DXH Class II 2008-12-15
K083335 MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM Omnisonics Medical Technologies QEY Class II 2008-12-15
K073417 EMBOZENE MICROSPHERES Celonova Biosciences, Inc. KRD Class II 2008-12-15
K083402 AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 St Jude Medical DYB Class II 2008-12-15
K082755 SEDAT FLAMINGO Sedat MAV Class II 2008-12-15
K083093 CHEETAH RELIANT Cheetah Medical, Inc. DSB Class II 2008-12-15
K082090 9131 DEFIBRILLATION ELECTRODES Cardiac Science Corporation MKJ Class III 2008-12-12
K082382 ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 Possis Medical, Inc. QEZ Class II 2008-12-12
K082932 CPS AIM SL SLITTABLE INNER CATHETER St Jude Medical DQY Class II 2008-12-12
K081852 TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 Truly Instrument Limited DXN Class II 2008-12-12

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