meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2010-10-26

Clearances · page 61 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102420 EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA Edwards Lifesciences, LLC DWF Class II 2010-10-26
K101355 AUGEASE VASCULAR AUGMENTATION DEVICE Augdvt, LLC JOW Class II 2010-10-26
K102135 VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM Nuvon, Inc. MWI Class II 2010-10-22
K103095 SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON Medtronic, Ireland LOX Class II 2010-10-22
K101839 KANEKA PHARMA AMERICA XPRESS-WAY RX Kaneka Pharma America, LLC QEZ Class II 2010-10-22
K102168 SENSEI X ROBOTIC CATHETER SYSTEM Hansen Medical, Inc. DXX Class II 2010-10-22
K102562 INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 Philips Medizin Systeme Boblingen GmbH MHX Class II 2010-10-21
K092641 CHARMCARE TABLETOP PULSE OXIMETER Charmcare Co., Ltd. DQA Class II 2010-10-21
K101896 MASIMO LNCS/M-LNCS OXIMETRY SENSORS Masimo Corporation DQA Class II 2010-10-21
K101497 DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor, Inc. DYB Class II 2010-10-20
K102426 CARESCAPE MODEL V100 VITAL SIGNS MONITOR Ge Medical Systems Information Technologies MWI Class II 2010-10-20
K092809 HRV ACQUIRE Wr Medical Electronics Co. DRT Class II 2010-10-19
K102732 VASOGRAD DVT COMPRESSION GARMENT Compression Therapy Concepts JOW Class II 2010-10-19
K102737 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER Covidien, LLC JOW Class II 2010-10-19
K093244 UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX Geratherm Medical AG DWJ Class II 2010-10-19
K102239 CARESCAPE MONITOR B650 GE Healthcare Finland Oy MHX Class II 2010-10-18
K102721 LIVEWIRE ELECTOPHYSIOLOGY CATHETER St Jude Medical DRF Class II 2010-10-18
K102920 ELECTRONIC BLOOD PRESSURE MONITOR Shenzhen Pango Electronic Co., Ltd. DXN Class II 2010-10-15
K101955 ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 St Jude Medical DRF Class II 2010-10-15
K101518 COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE Mirador Biomedical, Inc. DRS Class II 2010-10-13
K100310 BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS BTL Industries, Inc. MWJ Class II 2010-10-13
K101987 COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 Zoll Circulation NCX Class II 2010-10-12
K100071 EMCOOLSPAD Emcools Emergency Medical Cooling Systems AG NZE Class II 2010-10-12
K101331 LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE C.R. Bard Inc., Bard Electrophysiology Division DQK Class II 2010-10-08
K102728 ARSTASIS ACCESS SYSTEM Arstasis, Inc. DYB Class II 2010-10-07
K102582 ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE Devon Medical, Inc. JOW Class II 2010-10-07
K100077 NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 Solaris Medical Technology, Inc. DQA Class II 2010-10-07
K101280 MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE Midwest Reprocessing Center, LLC NLF Class II 2010-10-07
K102596 ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT Atrium Medical Corp. DSY Class II 2010-10-05
K101871 TRUSIGNAL SPO2 FINGERTIP SENSOR GE Healthcare Finland Oy DQA Class II 2010-10-04
K101148 WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS Cincinnati Sub-Zero Products, Inc. DWJ Class II 2010-10-01
K102468 ZOLL PROPAQ MD Zoll Medical Corporation, World Wide Headquarters LDD Class II 2010-09-30
K102495 M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 Philips Medical Systems MHX Class II 2010-09-30
K094062 PERCU-PRO GUIDEWIRE Cardiosolutions, Inc. DQX Class II 2010-09-27
K102040 PATIENT MONITOR Guangdong Biolight Meditech Co., Ltd. MHX Class II 2010-09-24
K101015 GUIDE CATHETERS AND ACCESSORIES Thomas Medical Products, Inc. DQY Class II 2010-09-23
K101729 NEOWIRE PTA/PTCA GUIDEWIRE Neometrics, Inc. DQX Class II 2010-09-23
K091561 ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE ZOLL Medical Corporation MKJ Class III 2010-09-23
K100578 ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S Asahi Intecc Co., Ltd. DQX Class II 2010-09-22
K101983 CRITICAL CARE ASSESSMENT Critical Patient Care, Inc. JOM Class II 2010-09-21
K101740 ALBOSURE POLYESTER VASCULAR PATCH LeMaitre Vascular, Inc. DXZ Class II 2010-09-20
K101568 MODEL SB100II FINGER PULSE OXIMETER Atlantean DQA Class II 2010-09-20
K093694 GERATHERM UNIQUERESC Geratherm Medical AG DWJ Class II 2010-09-20
K102356 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 Andon Health Co, Ltd. DXN Class II 2010-09-20
K101589 BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS Cincinnati Sub-Zero Products, Inc. DWJ Class II 2010-09-20
K100969 WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N Wmi Enterprises, LLC JOW Class II 2010-09-20
K102353 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 Andon Health Co, Ltd. DXN Class II 2010-09-17
K101968 SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A St Jude Medical MXC Class II 2010-09-15
K102174 ZOLL PROPAQ M Zoll Medical Corporation, World Wide Headquarters DRT Class II 2010-09-15
K091952 ACTA VESSEL OCCLUSION SYSTEM (VOS) Nfocus Neuromedical, Inc. KRD Class II 2010-09-10
K102442 E.S.O. (ELECTRO SENSOR OXI) Ld Technology, LLC DQA Class II 2010-09-10
K102430 TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET Tyco Electronics Corporation DSA Class II 2010-09-10
K102303 BLOOD PRESSURE METER, MODEL CH-658 Citizen Systems Japan Co., Ltd. DXN Class II 2010-09-10
K102004 ENDEAVOUR MONITORING SYSTEM Mindray DS USA, Inc. MHX Class II 2010-09-10
K101885 MEDTRONIC C315 DELIVERY CATHETER Medtronic, Inc. DQY Class II 2010-09-09
K101694 HANDHELD PULSE OXIMETER MODEL M800 Guangdong Biolight Meditech Co., Ltd. DQA Class II 2010-09-08
K101883 6F ENGAGE/ENGAGE TR INTRODUCER St Jude Medical DYB Class II 2010-09-07
K101186 AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG Medtronic Perfusion Systems DTP Class II 2010-09-03
K101834 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM 3M Company DRG Class II 2010-09-03
K102211 CRUISER 18 GUIDEWIRE Brivant, Ltd. DQX Class II 2010-09-03
K101602 VITAL SIGNS MONITOR Criticare Systems, Inc. MLD Class II 2010-09-01
K102176 FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 Medtronic Cryocath, LP DRA Class II 2010-09-01
K100518 INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 Instrumed International, Inc. DWP Class II 2010-08-31
K101600 INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL Philips Medizinsysteme Boeblingen GmbH, Cardiac AN DQA Class II 2010-08-31
K101339 ARCHER SUPER STIFF GUIDEWIRES Medtronic, Inc. DQX Class II 2010-08-31
K101950 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 Andon Health Co, Ltd. DXN Class II 2010-08-31
K092449 BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2010-08-30
K100055 BLOOD PRESSURE METER, MODEL CH-609 Citizen Systems Japan Co., Ltd. DXN Class II 2010-08-30
K101702 MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS Midwest Reprocessing Center, LLC JOW Class II 2010-08-27
K101330 MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE Midwest Reprocessing Center, LLC JOW Class II 2010-08-27
K100763 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 Microlife Intellectual Property GmbH DXN Class II 2010-08-27
K102129 LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR Levitronix, LLC DWA Class II 2010-08-27
K101892 HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- Heine Optotechnik GmbH & Co. KG DXQ Class II 2010-08-27
K093847 DUFLO CATHETER (HEPARIN COATED) Thermopeutix, Inc. MJN Class II 2010-08-25
K101789 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. NLH Class II 2010-08-19
K101623 INQUIRY AFOCUSII DIAGNOSTIC CATHETER St Jude Medical DRF Class II 2010-08-13
K101150 PICC WAND PEELABLE SAFETY INTRODUCER Access Scientific, Inc. DYB Class II 2010-08-13
K101660 ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 Kepler Medtec DSA Class II 2010-08-11
K101052 OMNI III PATIENT MONITOR Infinium Medical MWI Class II 2010-08-11
K101479 WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical DQY Class II 2010-08-11
K102025 COMBAT READY CLAMP Combat Medical Systems, LLC DXC Class II 2010-08-11
K101212 MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R Medtronic, Inc. KRH Class II 2010-08-07
K101542 HEADWAY 17 ADVANCED MICROCATHETER MicroVention, Inc. DQY Class II 2010-08-06
K102022 WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S Avinger, Inc. DQY Class II 2010-08-06
K101915 VASOPRESS SUPREME MINI MODEL VP500DM Compression Therapy Concepts, Inc. JOW Class II 2010-08-06
K101591 STINGRAY ORIENTING BALLOON CATHETER Bridgepoint Medical DQY Class II 2010-08-06
K100376 EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 Earlysense, Ltd. MSX Class II 2010-08-06
K101877 OCCLUSION BALLOON CATHETER MODEL OBC Cook, Inc. DQY Class II 2010-08-06
K101647 WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 Avinger, Inc. DQY Class II 2010-08-06
K101198 CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K Computerized Screening, Inc. DXN Class II 2010-08-04
K101361 REEFLEX PTA CATHETER ClearStream Technologies , Ltd. LIT Class II 2010-08-04
K100819 THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER Onset Medical Corporation DYB Class II 2010-08-02
K101010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 Andon Health Co, Ltd. DXN Class II 2010-07-30
K101521 ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O Philips Medical Systems MHX Class II 2010-07-29
K100654 ZOLL PROPAQ MD Zoll Medical Corporation, World Wide Headquarters LDD Class II 2010-07-29
K101826 HYDROFIX VASO SHIELD, MODEL HVS-001-0610 Mimedx Group, Inc. OMR Class II 2010-07-28
K101615 POWERWIRE RADIOFREQUENCY GUIDEWIRE Baylis Medical Co., Inc. PDU Class II 2010-07-28
K100813 QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB Pulse Biomedical, Inc. DPS Class II 2010-07-23
K101777 PIONEER PLUS CATHETER, MODEL PLUS 120 Medtronic Vascular PDU Class II 2010-07-23
K100133 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 Airstrip Technologies, LP MWI Class II 2010-07-23

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