meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2006-07-12

Clearances · page 78 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K061363 AGILIS NXT STEERABLE INTRODUCER St Jude Medical DYB Class II 2006-07-12
K060643 QL LOCKING SYRINGE Atrion Medical Products, Inc. MAV Class II 2006-07-12
K061619 INSPECTRA STO2 TISSUE OXYGENATION MONITOR Hutchinson Technology, Inc. MUD Class II 2006-07-12
K061452 TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM Tung FU Electric Co., Ltd. DXN Class II 2006-07-12
K061816 GALAXY Larsen & Toubro Limited MWI Class II 2006-07-12
K061772 TRIACTIV FX EMBOLIC PROTECTION SYSTEM Kensey Nash Corp. NFA Class II 2006-07-11
K061212 BIOTRONIK ENDOCARDIAL PACING LEADS Biotronik, Inc. DTB Class III 2006-07-10
K061329 INFINITY MASIMO SET SP02 POD Draeger Medical Systems, Inc. DQA Class II 2006-07-07
K060902 STARCLOSE INTRODUCER SET MODEL- 1002 Abbott Vascular, Inc. DYB Class II 2006-07-07
K053372 LBI CATHETER SYSTEM Lumen Biomedical, Inc. QEZ Class II 2006-06-30
K061558 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U Microlife Intellectual Property GmbH DXN Class II 2006-06-29
K051278 GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) Rg Ent., Inc. DWJ Class II 2006-06-29
K060759 Y-CLICK CONNECTOR Elcam Medical Acal DTL Class II 2006-06-29
K051336 GERATHERM SOS-RESCUE BAG R.G. Enterprises, Inc. DWJ Class II 2006-06-29
K060666 CAROTID ACCESS KIT Terumo Medical Corp. DYB Class II 2006-06-29
K060616 NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 PHD Medical DQA Class II 2006-06-29
K060848 BOD POD Life Measurement, Inc. OAC Class II 2006-06-27
K061527 CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING Sorin Group Italia S.R.L. DTN Class II 2006-06-27
K061161 BLOOD PRESSURE METER, MODEL CH-311B Citizen Watch Co., Ltd. DXN Class II 2006-06-26
K061159 OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN Hospira, Inc. DQE Class II 2006-06-26
K060281 VS-800 VITAL SIGNS MONITOR Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2006-06-23
K061254 EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 Medtronic Perfusion Systems DWF Class II 2006-06-23
K060745 ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY Asahi Intecc Co., Ltd. DQY Class II 2006-06-23
K053195 SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. NFA Class II 2006-06-23
K052908 INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 Infraredx, Inc. DQO Class II 2006-06-23
K052767 AFIBALERT ATRIAL FIBRILLATION DETECTOR Lechnologies Research, Inc. DXH Class II 2006-06-23
K061453 HI-TORQUE WHISPER VIEW GUIDE WIRE Guidant Corp. DQX Class II 2006-06-22
K061456 A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 2006-06-21
K061606 DEFIBRILLATOR CABLE TESTER, MODEL DT2200 Medical Devices/Padpro, Inc. DRG Class II 2006-06-21
K061590 SMDIE DEVICE INTERFACING SYSTEM Siemens Medical Solutions Health Services Corporat MWI Class II 2006-06-21
K061546 QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 Maquet Cardiopulmonary, AG DTM Class II 2006-06-20
K060047 CARTO RMT EP NAVIGATION SYSTEM V8 Biosense Webster, Inc. DRF Class II 2006-06-19
K053400 ACUMEN SINGLE-LUMEN DELIVERY SHEATH Acumen Medical, Inc. DYB Class II 2006-06-19
K060143 LNCS AND SPO2.COM SENSORS Masimo Corporation DQA Class II 2006-06-16
K060524 DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES Dolphin Medical, Inc. DQA Class II 2006-06-15
K053381 WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE Welch Allyn, Inc. DQA Class II 2006-06-15
K061403 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U Microlife Intellectual Property GmbH DXN Class II 2006-06-14
K061088 SENTRY OTC MONITOR Honeywell Hommed, LLC DRG Class II 2006-06-09
K060766 PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 Omron Healthcare, Inc. DPS Class II 2006-06-09
K060686 MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC Microlife Intellectual Property GmbH DXN Class II 2006-06-09
K061087 GENESIS OTC MONITOR Honeywell Hommed, LLC DRG Class II 2006-06-09
K060871 AS101, BLOOD PRESSURE CUFF Wenzhou Longwan Medical Instrument Company DXQ Class II 2006-06-09
K060642 DUTECK BODY COMPOSITION ANALYZER Duteck Industrial Co., Ltd. MNW Class II 2006-06-07
K060551 BRIVANT GUIDEWIRE Brivant Limited DQX Class II 2006-06-07
K060820 CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 Suntech Medical, Inc. DXN Class II 2006-06-07
K052601 STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH DWC Class II 2006-06-06
K061031 D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W Sorin Group Italia S.R.L. DTZ Class II 2006-06-02
K061073 CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250 Taidoc Technology Corporation DXN Class II 2006-06-02
K060053 STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH DTQ Class II 2006-06-02
K061171 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX Biosphere Medical, Inc. DQX Class II 2006-06-02
K060449 HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE Guidant Corporation DQX Class II 2006-05-30
K061052 THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 Philips Medical Systems North America, Inc. MHX Class II 2006-05-26
K061059 MODIFIED MERCI RETRIEVER, MODEL 90092 Concentric Medical, Inc. NRY Class II 2006-05-25
K052511 CARDIOFAX CE, MODEL ECG-1500 A Nihon Kohden America, Inc. DPS Class II 2006-05-24
K060552 BC100 BODY COMPOSITION ANALYSIS SYSTEM Athletic Iq, Inc. MNW Class II 2006-05-24
K061125 DVTCARE CA5 Doctors Orders JOW Class II 2006-05-23
K061072 ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 Maquet Cardiopulmonary, AG KFM Class II 2006-05-23
K061127 CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R Medtronic Vascular KRH Class II 2006-05-23
K061191 FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 Measurement Specialties, Inc. DQA Class II 2006-05-22
K061112 CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M Conmed Corporation DQA Class II 2006-05-22
K053207 ARGUS, MODEL LCM Schiller AG MHX Class II 2006-05-19
K061119 ENPATH MEDICAL STEERABLE SHEATH Enpath Medical, Inc. DQY Class II 2006-05-18
K053193 PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MWI Class II 2006-05-18
K061063 MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 Foxhollow Technologies, Inc. MCW Class II 2006-05-18
K052691 SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES Suretek Medical JOW Class II 2006-05-17
K060934 MODIFICATION TO POWERHEART ECD Cardiac Science Corporation MKJ Class III 2006-05-15
K061185 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE GE Healthcare MHX Class II 2006-05-15
K060321 ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK American Diagnostic Corp. DQD Class II 2006-05-15
K060135 MORTARA SURVEYOR TELEMETRY CENTRAL STATION Mortara Instrument, Inc. MHX Class II 2006-05-15
K060116 MICRUS COURIER MICROCATHETERS Micrus Endovascular Corporation DQO Class II 2006-05-12
K060396 IVENA VASCULAR PATCH Atrium Medical Corp. DXZ Class II 2006-05-12
K053419 KONICA MINOLTA PULSOX-300, 300I Konica Minolta Sensing, Inc. DQA Class II 2006-05-11
K061000 EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 Cook Vascular, Inc. DRE Class II 2006-05-10
K060101 ESTECH AORTIC EASY FLOW CANNULA Endoscopic Technologies, Inc. DWF Class II 2006-05-10
K060925 ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 ACON Laboratories, Inc. DXN Class II 2006-05-09
K053453 HOMMED CENTRAL STATION, VERSION 3.5 Honeywell Hommed, LLC DXN Class II 2006-05-05
K060519 INTRODUCER ASSEMBLY WITH ROTATOR LOCK Teleflex Medical DYB Class II 2006-05-05
K051760 NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 Stereotaxis, Inc. DXX Class II 2006-05-05
K052392 HOT DOG PATIENT WARMING SYSTEM Augustine Biomedical & Design, LLC DWJ Class II 2006-05-04
K053188 REPROCESSED BALOON INFLATION DEVICE Sterilmed, Inc. NKU Class II 2006-05-04
K060065 CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR Oridion Capnography, Inc. DQA Class II 2006-05-04
K053234 PM-9000 EXPRESS PATIENT MONITOR Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MWI Class II 2006-05-04
K060904 CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical, L.P. MCW Class II 2006-04-28
K053265 MICRUS GUIDE WIRE, WATUSI 0.014 Micrus Endovascular Corporation DQX Class II 2006-04-28
K060093 PRESEP OLIGON OXIMETRY CATHETERS Edwards Lifesciences, LLC DQE Class II 2006-04-28
K053491 PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F Penumbra, Inc. DQY Class II 2006-04-27
K053187 AMPLATZER NOODLEWIRE GUIDEWIRE Aga Medical Corp. DQX Class II 2006-04-27
K051419 INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 Inditherm Medical DWJ Class II 2006-04-27
K060308 COOLGARD 3000 Alsius Corp. NCX Class II 2006-04-26
K052611 ECP HEALTH SYSTEM, MODEL 2005 Ecp Health, Inc. DRN Class II 2006-04-26
K060660 EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER Edwards Lifesciences, LLC DXG Class II 2006-04-25
K060016 THROMCAT THROMBECTOMY CATHETER SYSTEM Kensey Nash Corp. MCW Class II 2006-04-25
K053263 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 Cardionet, Inc. DSI Class II 2006-04-25
K050674 PHYSIOGLOVE ES Commwell , Ltd. DPS Class II 2006-04-25
K060865 BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 Arizant Healthcare, Inc. DWJ Class II 2006-04-24
K060807 SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM Biotronik, Inc. DQY Class II 2006-04-24
K060954 MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 St. Jude Medical, Inc.-Endocardial Solutions DQK Class II 2006-04-21
K060835 HL888SF Health & Life Co., Ltd. DXN Class II 2006-04-21
K060843 MODIFICATION TO HEALTH BUDDY APPLIANCE Health Hero Network, Inc. DQA Class II 2006-04-20
K060757 INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER Irvine Biomedical, Inc. DRF Class II 2006-04-19

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