meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
2009-11-03

Clearances · page 65 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K092368 REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. NLF Class II 2009-11-03
K091927 INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN DSI Class II 2009-11-03
K092364 MODEL 220 PATIENT MAGNET Cyberonics, Inc. DTG Class I 2009-11-03
K092378 SPECTRANETICS VISISHEATH DILATOR SHEATH Spectranetics Corp. DRE Class II 2009-11-02
K092623 F.A.S.T. SYSTEM SED AND CXD Genesis Medical Interventional, Inc. QEW Class II 2009-10-30
K092361 REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER Invatec S.P.A. LIT Class II 2009-10-29
K090689 QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 Maquet Cardiopulmonary, AG DTZ Class II 2009-10-29
K093023 PTFE PEELABLE INTRODUCER Great Batch Medical DYB Class II 2009-10-29
K092245 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 Honsun (Nantong) Co., Ltd. DXQ Class II 2009-10-28
K093002 AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 MicroVention, Inc. KRD Class II 2009-10-28
K092303 MERIT LAUREATE HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2009-10-27
K092544 INSTRUMED VASCULAR CLAMPS Instrumed International, Inc. DXC Class II 2009-10-26
K091696 SAVI WIRELESS, MODEL PM500 Medicomp, Inc. DRG Class II 2009-10-26
K092456 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C Microlife Intellectual Property GmbH DXN Class II 2009-10-23
K092010 PC ECG, MODEL SE-1010 Edan Instruments, Inc. DPS Class II 2009-10-22
K092425 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 Ascent Healthcare Solutions OWQ Class II 2009-10-21
K092101 REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES Nonin Medical, Inc. DQA Class II 2009-10-21
K092604 LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX Trimline Medical Products Corp. DXQ Class II 2009-10-21
K091414 VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH Biocare Corp. DXN Class II 2009-10-21
K091542 ESTECH EASYFLOW CANNULA WITH GUIDEWIRE Endoscopic Technologies, Inc. D/B/A Estech DWF Class II 2009-10-20
K090487 DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 Coeur, Inc. DXT Class II 2009-10-19
K092895 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Sorin Group Italia S.R.L. DTZ Class II 2009-10-19
K092913 EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 Ep Medsystems JOQ Class II 2009-10-16
K092876 SJM ATTUNE ANNULOPLASTY RING St Jude Medical KRH Class II 2009-10-16
K091780 GUIDED MEASUREMENT CATHETER (GMC) Mediguide, Ltd. DQO Class II 2009-10-16
K091781 GUIDED MEDICAL POSITIONING SYSTEM (GMPS) Mediguide, Ltd. DQK Class II 2009-10-16
K091458 HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 Ev3 Neurovascular MJN Class II 2009-10-15
K090006 LIFEBRIDGE B2T, MODEL 7001 Lifebridge Medizintechnik AG DTQ Class II 2009-10-15
K091624 STENT GRAFT BALLOON CATHETER Via Biomedical, Inc. DQY Class II 2009-10-15
K092177 MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 Invatec S.P.A. NTE Class II 2009-10-15
K092838 MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 Masimo Corporation DQA Class II 2009-10-15
K091369 ELECTROFLUIDGRAPH Akern USA, LLC MNW Class II 2009-10-14
K091703 HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 Concentric Medical, Inc. QEZ Class II 2009-10-14
K092408 RHYTHM OF LIFE, MODEL R0901-05 Rapid Response Solutions, LLC LIX Class II 2009-10-14
K092389 DISPOSAL ECG ELECTRODES, MODEL EASYRODE Suzuken Co., Ltd. DRX Class II 2009-10-13
K090017 CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES Biosense Webster, Inc. DQK Class II 2009-10-13
K092810 EP-WORKMATE SYSTEM, VERSION 4.2 St Jude Medical DQK Class II 2009-10-09
K091787 MODEL 6000 TWO PARAMETER BEDSIDE MONITOR Ivy Biomedical Systems, Inc. DQA Class II 2009-10-09
K092806 AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 K-Jump Health Co., Ltd. DXN Class II 2009-10-09
K091584 MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE Merit Medical Systems, Inc. DRE Class II 2009-10-09
K092432 AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) Jawon Medical Co., Ltd. DXN Class II 2009-10-09
K092105 RADIANALYZER XPRESS Radi Medical Systems AB DQK Class II 2009-10-09
K092575 ENGAGE/ENGAGE TR St Jude Medical DYB Class II 2009-10-08
K092509 EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE Edwards Lifesciences, LLC DWF Class II 2009-10-08
K090051 LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 Levitronix, LLC KFM Class II 2009-10-08
K092014 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER Onset Medical Corporation DYB Class II 2009-10-08
K092863 MAXIFLO, TAPERFLO Vascutek, Ltd. DSY Class II 2009-10-08
K092431 BODY COMPOSITION ANALYZER, MODEL: IOI 353 Jawon Medical Co., Ltd. MNW Class II 2009-10-08
K092037 LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM Hoana Medical, Inc. DRT Class II 2009-10-02
K092711 GUARDIAN II HEMOSTASIS VALVE Zerusa Limited DTL Class II 2009-10-01
K092678 EVISION DATA MANAGEMENT SOFTWARE Nonin Medical, Inc. DQA Class II 2009-10-01
K091789 CARTO RMT EP NAVIGATION SYSTEM V8 Biosense Webster, Inc. DQK Class II 2009-10-01
K092161 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF Health & Life Co., Ltd. DXN Class II 2009-09-30
K091825 HI-TORQUE PROGRESS GUIDE WIRE FAMILY Abbott Vascular, Inc. DQX Class II 2009-09-25
K090193 CONDUCTOR CORONARY GUIDEWIRE Concert Medical, LLC DQX Class II 2009-09-25
K092683 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 Shanghai Little Doctor Co. Limited DXN Class II 2009-09-25
K090932 NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 Nexgen Medical Systems, Inc. QEW Class II 2009-09-24
K091972 MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01 Stethoscope Technologies, Inc. DQD Class II 2009-09-23
K092680 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN GE Healthcare Finland Oy MHX Class II 2009-09-23
K090989 ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES Zoll Medical Corp MKJ Class III 2009-09-23
K092495 HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 Ev3 Neurovascular MJN Class II 2009-09-22
K091572 DISPOSABLE SPO2 SENSOR M1134A Philips Medizinsysteme Boeblingen GmbH, Cardiac AN DQA Class II 2009-09-22
K091553 BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE Ningbo Diaier Electronic Co., Ltd. DXN Class II 2009-09-21
K091220 HEALTHANYWHERE SYSTEM Healthanywhere, an Igeacare System Company DRG Class II 2009-09-21
K090752 PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 Penumbra, Inc. NRY Class II 2009-09-21
K091559 MARKSMANN CATHETER Chestnut Medical Technologies, Inc. KRA Class II 2009-09-18
K092719 DIGITAL BLOOD PRESSURE MONITOR Shanghai Little Doctor Electronic Co., Ltd. DXN Class II 2009-09-18
K090449 MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT Gish Biomedical, Inc. DTZ Class II 2009-09-18
K090450 MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT Gish Biomedical, Inc. DTZ Class II 2009-09-18
K091268 HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS Hospira, Inc. DQE Class II 2009-09-18
K083715 BELTBEAT WF-400 Bonus Communicaciones Srl DPS Class II 2009-09-15
K092372 HEARTRAIL III GUIDING CATHETER Terumo Corp. DQO Class II 2009-09-11
K091808 SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 Hansen Medical, Inc. DXX Class II 2009-09-10
K092635 ALCATEL-LUCENT TELEHEATH MANAGER Alcatel-Lucent Canada, Inc. DRG Class II 2009-09-10
K091943 POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A Cardiac Science Corporation MKJ Class III 2009-09-10
K091434 TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M Truly Instrument Co., Ltd. DXN Class II 2009-09-04
K092576 GEM HEART ONE/ONE+ Gem-Med S.L. DPS Class II 2009-09-04
K092455 MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation LIT Class II 2009-09-04
K091415 TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M Truly Instrument Co., Ltd. DXN Class II 2009-09-04
K092396 SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS Spectranetics Corp. DQY Class II 2009-09-04
K090898 CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER Biosense Webster, Inc. DRF Class II 2009-09-04
K092324 SPIROPRO Viasys Healthcare GmbH DQA Class II 2009-09-03
K092332 JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) Pathway Medical Technologies, Inc. MCW Class II 2009-09-03
K091841 BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 Bridgepoint Medical DQY Class II 2009-09-02
K090496 QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH Cardiac Lead Technologies, Inc. DRX Class II 2009-09-01
K090394 VALVED TEARWAY INTRODUCER Medcomp DYB Class II 2009-09-01
K091778 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS Vascutek, Ltd. DSY Class II 2009-08-31
K092027 CARESCAPE MONITOR B850 Ge Medical Systems Information Technologies MHX Class II 2009-08-28
K092486 VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT Vortex Medical, Inc. DWE Class II 2009-08-28
K090869 MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD Medtronic Perfusion Systems DWF Class II 2009-08-27
K092310 SEGUIN ANNULOPLASTY RING St Jude Medical KRH Class II 2009-08-27
K091971 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM Corventis, Inc. DSI Class II 2009-08-27
K092286 FOX SV PTA CATHETER Abbott Vascular LIT Class II 2009-08-27
K091897 BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 Taidoc Technology Corporation DXN Class II 2009-08-25
K091821 COMMANDER 111, MODEL CD300-CD399 Cardiocom, LLC DXN Class II 2009-08-25
K090936 SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A Contec Medical System Co., Ltd. DPS Class II 2009-08-25
K092291 SKINTACT AND VARIOUS OTHER TRADENAMES Leonhard Lang GmbH DRX Class II 2009-08-21
K091430 CARE PAL, MODEL CPW-10X Digio2 International Co., Ltd. DRG Class II 2009-08-21
K091452 FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) Cas Medical Systems, Inc. MUD Class II 2009-08-21
K083448 CABLE, TRANSDUCER, MODEL 2400GN Conmed Corporation DQA Class II 2009-08-20

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