meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2006-04-19

Clearances · page 79 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K053356 MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION Ge Medical Systems Information Technologies DXJ Class II 2006-04-19
K060712 VITELCARE C-TURTLE PATIENT MONITORING SYSTEM Visual Telecommunications Network, Inc. MWI Class II 2006-04-19
K060167 ATRIA 3100, ATRIA 6100 Cardiac Science Corporation DPS Class II 2006-04-19
K052243 PROACT WITH GEL OR PROACT 1 Proact, Inc. JOW Class II 2006-04-12
K060729 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV Health & Life Co., Ltd. DXN Class II 2006-04-12
K060327 VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER Vascular Solutions, Inc. DQY Class II 2006-04-12
K060960 BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER Boston Scientific Corporation LIT Class II 2006-04-12
K060223 INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM Draeger Medical Systems, Inc. MHX Class II 2006-04-12
K060959 SYMMETRY BALLOON DILATATION CATHETER Boston Scientific Corporation LIT Class II 2006-04-12
K060039 INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS Draeger Medical Systems, Inc. MHX Class II 2006-04-12
K051984 FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 Boston Scientific Corp NFA Class II 2006-04-10
K060661 MACTRODE 3 Ge Medical Systems Information Technologies DRX Class II 2006-04-07
K051227 RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 Renu Medical, Inc. JOW Class II 2006-04-07
K060315 HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM Healthstats International Pte. , Ltd. DXN Class II 2006-04-07
K060309 AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES Arrow Intl., Inc. DSP Class II 2006-04-06
K053121 TRAM MODULE GE Healthcare MHX Class II 2006-04-05
K060741 SWIRLGRAFT VASCULAR ACCESS GRAFT Veryan Medical Limited DSY Class II 2006-04-05
K060190 SUPER SHEATH XL INTRODUCER SHEATH Togo Medikit Co., Ltd. DYB Class II 2006-04-04
K052319 IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 Impedimed Pty , Ltd. MNW Class II 2006-04-04
K060703 PMP4 BP PRO BLOOD PRESSURE MONITOR Card Guard Scientific Survival , Ltd. DXN Class II 2006-04-04
K060254 MODIFICATION TO INFINITY EXPLORER Draeger Medical Systems, Inc. MSX Class II 2006-04-04
K060342 ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K Rossmax International , Ltd. DXN Class II 2006-04-04
K051438 VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) Alliance Medical, Inc. JOW Class II 2006-04-04
K060655 SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H Biotronik, Inc. DQY Class II 2006-04-04
K060124 ATRIUM FLIXENE GRAFT Atrium Medical Corp. DSY Class II 2006-03-30
K052693 PM-50 PULSE OXIMETER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DQA Class II 2006-03-30
K051670 RF TUNNELER WIRE Baylis Medical Co., Inc. PDU Class II 2006-03-30
K060197 ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 Zargis Medical Corp. DQD Class II 2006-03-29
K053300 SYVEKEXCEL Marine Polymer Technologies, Inc. DXC Class II 2006-03-28
K052898 IQMARK EZ STRESS Brentwood Medical Technology Corp. DPS Class II 2006-03-28
K060541 THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS Philips Medizin Systeme Boblingen GmbH MHX Class II 2006-03-24
K060175 ISIGHT IMAGING CATHETER, MODEL 38986 Boston Scientific Corp DQO Class II 2006-03-24
K060454 TITAN GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2006-03-24
K053582 INQUIRY AFOCUS II DIAGNOSTIC CATHETER Irvine Biomedical, Inc. DRF Class II 2006-03-21
K052844 KAVS - CATHETER, MODELS 1107100 & 1107060 Richter & Rothe AG MJN Class II 2006-03-20
K053431 ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM Medtronic, Ireland DQY Class II 2006-03-16
K051675 BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER Biodynamics Corp. MNW Class II 2006-03-16
K053477 MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS Masimo Corporation DQA Class II 2006-03-16
K052555 MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB Rand S.R.L. DTQ Class II 2006-03-15
K060572 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation DQY Class II 2006-03-15
K060418 8F SHERPA NX GUIDE CATHETER Medtronic Vascular DQY Class II 2006-03-15
K060504 IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001 Ideal Life, Inc. DXN Class II 2006-03-14
K053268 PVS 2000 SYNCHRO2 GUIDEWIRE Boston Scientific - Precision Vascular DQX Class II 2006-03-13
K053398 COMPASS COMPRESSION ASSIST HANDLE Semler Technologies, Inc. Dba DXC Class II 2006-03-10
K060422 LYSUS INFUSION SYSTEM Ekos Corp. QEY Class II 2006-03-09
K053194 NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE Biosense Webster, Inc. DQK Class II 2006-03-09
K060092 QUICKCAT EXTRACTION CATHETER Kensey Nash Corp. QEZ Class II 2006-03-09
K053645 MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS Arizant Healthcare, Inc. DWJ Class II 2006-03-09
K052637 THEROX INFUSION CATHETER, MODEL INCA-1 Therox, Inc. DQO Class II 2006-03-08
K052989 DP240 240 HOUR DOPPLER PROBE Deltex Medical DPT Class II 2006-03-08
K053251 TECHDEVICE GUIDEWIRE Techdevice Corporation DQX Class II 2006-03-08
K060146 ACTIVECARE ++ SYSTEM Medical Compression Systems (Dbn) , Ltd. JOW Class II 2006-03-08
K053217 CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 St Jude Medical DQY Class II 2006-03-08
K060077 RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A Real Tone Technology Corp. DXN Class II 2006-03-08
K060224 MODIFICATION TO MIRA-FLEX 18 MICROCATHETER Cook Incorporated KRA Class II 2006-03-06
K053019 ACUITY STEERABLE STYLET ACCESSORY Guidant Corporation DRB Class II 2006-03-03
K051907 INNOCOR Innovision A/S DQK Class II 2006-03-02
K053609 PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR Edwards Lifesciences, LLC DQE Class II 2006-02-28
K052450 KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR Kodon(Tianjin)Electronic&Electrical Apparatus Co., DXN Class II 2006-02-28
K051137 TECHDEVICE OCCLUSION BALLOON CATHETER Techdevice Corporation MJN Class II 2006-02-24
K051097 GERATHERM SOS-RESCUE BLANKET Rg Ent., Inc. DWJ Class II 2006-02-24
K060049 REPROCESSED COMPRESSION SLEEVES Alliance Medical Corp. JOW Class II 2006-02-24
K053277 CPS DIRECT SL OUTER CATHETER St Jude Medical DQY Class II 2006-02-24
K053378 LOOP RECORDER VITAPHONE, 3100 SERIES Tms Telemedizinische Systeme GmbH DXH Class II 2006-02-23
K053484 INFINITY GAMMA / GAMMAXL, INFINITY VISTA Draeger Medical Systems, Inc. MHX Class II 2006-02-22
K052057 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Emergency Response Systems, Inc. MKJ Class III 2006-02-17
K060091 ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES Alliance Medical Corp. JOW Class II 2006-02-17
K060221 THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH MHX Class II 2006-02-17
K052659 SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. NTE Class II 2006-02-17
K052676 KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Kodon(Tianjin)Electronic&Electrical Apparatus Co., DXN Class II 2006-02-17
K052828 DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) Hospira, Inc. DRS Class II 2006-02-17
K052347 TITAN STEERABLE (PTCA) GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2006-02-17
K053575 HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS Hygia Health Services, Inc. JOW Class II 2006-02-15
K060194 MARCH HEALTHCARE HEALTH MONITORING KIT March Healthcare Corporation DXN Class II 2006-02-13
K053316 REPROCESSED COMPRESSION SLEEVES Alliance Medical Corp. JOW Class II 2006-02-13
K052965 EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. Guidant Corporation DRB Class II 2006-02-13
K060220 PBS MODEL 701A COMPRESSION THERAPY DEVICE Mego Afek JOW Class II 2006-02-09
K053618 INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 Hutchinson Technology, Inc. MUD Class II 2006-02-08
K060084 LYSUS INFUSION SYSTEM Ekos Corp. QEY Class II 2006-02-07
K060142 VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS Vascutek, Ltd. DSY Class II 2006-02-07
K052671 HOCA EZ-CARE BP108, TENDER-CARE BP109 Hoca Medical Microsystem, Inc. DXN Class II 2006-02-03
K053006 ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II Rossmax Internationl , Ltd. DXQ Class II 2006-02-03
K051217 DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) GE Healthcare MHX Class II 2006-02-03
K052446 LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM Hoana Medical, Inc. DRT Class II 2006-02-02
K052608 TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) Bl Healthcare, Inc. DRG Class II 2006-02-01
K053403 LUCAS Jolife AB DRM Class II 2006-02-01
K060078 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corporation KRD Class II 2006-01-31
K053112 BIOSIGN Oxford Biosignals Limited MWI Class II 2006-01-31
K051163 GALIX ECG PROFESSIONAL STATION Galix Biomedical Instrumentation, Inc. DPS Class II 2006-01-31
K053630 LEVITRONIX CENTRIMAG PRIMARY CONSOLE Levitronix, LLC DWA Class II 2006-01-26
K053021 ESTECH CLEARVIEW MV ATRIAL DEPRESSOR Estech, Inc. DTS Class II 2006-01-26
K053185 PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Medwave, Inc. DXN Class II 2006-01-24
K052975 DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE GE Healthcare MSX Class II 2006-01-20
K051400 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS GE Healthcare MHX Class II 2006-01-20
K052854 LIFENET EXCHANGE SYSTEM Medtronic Emergency Response Systems, Inc. MSX Class II 2006-01-20
K060058 STELLAR 404T Larsen & Toubro Limited MWI Class II 2006-01-20
K053171 MERIT IMPRESS DIAGNOSTIC CATHETER Merit Medical Systems, Inc. DQO Class II 2006-01-19
K052575 LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN St Jude Medical DRA Class II 2006-01-19
K052004 VASCON NEUROPATH GUIDING CATHETER Vascon, LLC DQY Class II 2006-01-19
K053462 3160 MRI PATIENT MONITORING SYSTEM Invivo Corporation MWI Class II 2006-01-18

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