meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
2003-12-11

Clearances · page 88 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033600 INFINITY GAMMAXL Draeger Medical Systems, Inc. MHX Class II 2003-12-11
K033641 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 Cobe Cardiovascular, Inc. DTN Class II 2003-12-11
K033681 GLIDESHEATH Terumo Corp. DYB Class II 2003-12-11
K033714 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING Dideco S.P.A. DTN Class II 2003-12-11
K033708 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. DQX Class II 2003-12-11
K033025 TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700 Tytan Medical Corp. DXN Class II 2003-12-10
K031949 TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 Baylis Medical Co., Inc. DXF Class II 2003-12-10
K032841 MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR Moor Instruments, Ltd. DPT Class II 2003-12-10
K031599 CD LEYCOM PRESSURE/VOLUME CATHETERS Cd Leycom BV DQO Class II 2003-12-09
K033613 MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER Biotronik, Inc. DTA Class II 2003-12-08
K023414 MIDA ALGORITHM REV. B Ortivus AB DYC Class II 2003-12-05
K033542 EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE Galt Medical Corp. DQX Class II 2003-12-05
K032821 HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF Hygia Health Services, Inc. NPP Class II 2003-12-05
K032810 DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE Medtronic Heart Valves KRH Class II 2003-12-05
K031124 POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR Datex-Ohmeda, Inc. MHX Class II 2003-12-04
K032900 LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS Edwards Lifesciences, LLC DSY Class II 2003-12-04
K033281 DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE Datex-Ohmeda MSX Class II 2003-11-26
K032230 RHYTHM DIGITAL ELECTRONIC STETHOSCOPE Thinklabs, Inc. DQD Class II 2003-11-26
K032537 DRAEGER MICRO2+ AND MASIMO MINISAT Draeger Medical Systems, Inc. DQA Class II 2003-11-25
K031153 MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 Arrow Intl., Inc. DPW Class II 2003-11-25
K031722 JSA REPROCESSED COMPRESSION SLEEVE DEVICES Jack Speer and Assoc., Inc. JOW Class II 2003-11-25
K031340 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO Siemens Medical Solutions USA, Inc. MHX Class II 2003-11-25
K033492 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies MHX Class II 2003-11-24
K033441 BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER Boston Scientific Corp DQY Class II 2003-11-21
K033444 PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER Philips Medical Systems MHX Class II 2003-11-21
K031842 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. PDU Class II 2003-11-21
K032613 TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE Peter M. Rothenberg, M.D. LDF Class II 2003-11-20
K033320 SCOUT PRO Biotronik, Inc. DQY Class II 2003-11-19
K032869 COOK CODA BALLOON CATHETER Cook, Inc. DQY Class II 2003-11-19
K033188 TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 Idev Technologies, Inc. MMX Class II 2003-11-19
K033443 SPEEDLYSER INFUSION CATHETER KIT AngioDynamics, Inc. QEY Class II 2003-11-19
K032784 ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 Intra Luminal Therapeutics, Inc. DQY Class II 2003-11-18
K031515 SPIROPRO SPO2 Viasys Healthcare GmbH DQA Class II 2003-11-14
K033468 AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE Medtronic Perfusion Systems DTM Class II 2003-11-14
K032691 ZOLL AUTOCLAVABLE INTERNAL HANDLES Zoll Medical Corp LDD Class II 2003-11-13
K033144 DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES Defibtech, LLC MKJ Class III 2003-11-13
K031559 RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES Renu Medical, Inc. JOW Class II 2003-11-12
K033021 KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS Kimberly-Clark Corp. DWJ Class II 2003-11-12
K032852 MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 Revivant Corp. DRM Class II 2003-11-12
K032519 ENDO PAT 2000 Itamar Medical DQK Class II 2003-11-12
K033304 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR Ge Medical Systems Information Technologies MHX Class II 2003-11-12
K032871 PLANET MONITORING SYSTEM Larsen & Toubro Limited MWI Class II 2003-11-10
K032867 STAR (LUNAR SERIES) MONITORING SYSTEM Larsen & Toubro Limited MWI Class II 2003-11-10
K032308 BLOOD PRESSURE MONITOR, MODEL M100 Meditek Technology, Inc. DXN Class II 2003-11-10
K030359 KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Kodon(Tianjin)Electronic&Electrical Apparatus Co., DXN Class II 2003-11-06
K030419 VITERION 100 TELEHEALTH MONITOR Viterion Telehealthcare, LLC MWI Class II 2003-11-06
K033275 LIFEPAK 12, 20, 500, CR PLUS Medtronic Physio-Control Corp. MKJ Class III 2003-11-06
K033365 APEXPRO FH TELEMETRY SYSTEM Ge Medical Systems Information Technologies MHX Class II 2003-11-06
K033321 SELECTIVA SB GUIDEWIRE Neometrics, Inc. DQX Class II 2003-11-05
K032439 ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) Zoll Medical Corp MKJ Class III 2003-11-05
K033416 SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE Medtronic Perfusion Systems DWF Class II 2003-11-05
K033247 MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM Medrad, Inc. DXT Class II 2003-11-05
K031946 EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE Edwards Lifesciences, LLC DTM Class II 2003-11-03
K033264 MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES Medtronic Perfusion Systems DWF Class II 2003-10-31
K032363 ZOLL M SERIES NIBP OPTION Zoll Medical Corp DXN Class II 2003-10-31
K033037 MODIFICATION TO GLOBALCARDIO Cardiocomm Solutions, Inc. DSH Class II 2003-10-31
K031446 JABES ELECTRONIC STETHOSCOPE Gs Technology Co., Ltd. DQD Class II 2003-10-31
K033130 PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR Osypka Medical, Inc. DTE Class II 2003-10-31
K033217 PHERON PTA CATHETER Biotronik, Inc. DQY Class II 2003-10-31
K033305 INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM Draeger Medical Systems, Inc. DSI Class II 2003-10-31
K030358 KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Kodon(Tianjin)Electronic&Electrical Apparatus Co., DXN Class II 2003-10-31
K032145 AUDICOR UPGRADE SYSTEM Inovise Medical, Inc. DPS Class II 2003-10-31
K032426 GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET Cook, Inc. DTK Class II 2003-10-31
K032105 ENDOHELIX ENDARTERECTOMY DEVICE Endarx, Inc. DWX Class II 2003-10-30
K033211 ENSITE SYSTEM Endocardial Solutions, Inc. DQK Class II 2003-10-30
K032499 A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS A&D Engineering, Inc. DXN Class II 2003-10-30
K032513 T-WAVE ALTERNANS (TWA) ALGORITHM OPTION Ge Medical Systems Information Technologies DQK Class II 2003-10-30
K032387 TRIVEX SYSTEM Smith & Nephew, Inc. DWQ Class II 2003-10-29
K033078 DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE Datex-Ohmeda MSX Class II 2003-10-29
K032660 XTRAK SUPPORT CATHETER Xtrak Medical, Inc. DQY Class II 2003-10-29
K033283 CENTRA VIEW DEVICE LINK SYSTEM Icu Datasystems, Inc. MWI Class II 2003-10-27
K030421 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM Alsius Corp. NCX Class II 2003-10-23
K023723 FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 Fms, Finapres Medical Systems BV DXN Class II 2003-10-23
K030627 ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 C.R. Bard, Inc. DRF Class II 2003-10-23
K032632 REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH Estech, Inc. DWF Class II 2003-10-22
K032931 PTA BALLOON CATHETER Cook, Inc. DQY Class II 2003-10-22
K032312 ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM Medtronic Vascular DQY Class II 2003-10-21
K032947 NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 Dolphin Medical, Inc. DQA Class II 2003-10-17
K032899 RADIUS COUGAR WIRE Radius Medical Technologies, Inc. DQX Class II 2003-10-17
K030668 MODEL 3100 WRISTOX PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2003-10-17
K031189 UUHC REPROCESSED COMPRESSION SLEEVE DEVICES University of Utah Hospitals and Clinics JOW Class II 2003-10-16
K031074 DIGITAL AMBULATORY ECG (HOLTER) RECORDER Datrix MWJ Class II 2003-10-15
K032997 MODIFICATION TO: HORIZON 9000WS Mennen Medical , Ltd. DXG Class II 2003-10-15
K032926 EKG SPEAKS Medtronic Vascular KRE Class II 2003-10-15
K033214 EKOS PERIPHERAL INFUSION SYSTEM Ekos Corp. QEY Class II 2003-10-14
K031465 MODEL 2100 PULSE OXIMETER Dolphin Medical, Inc. DQA Class II 2003-10-10
K032577 MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM Ge Medical Systems Information Technologies DQK Class II 2003-10-10
K031195 CUF-COVER (TM) Ethox Corp. DXQ Class II 2003-10-10
K032290 FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. MHX Class II 2003-10-10
K032858 THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. Philips Medizin Systeme Boblingen GmbH DSI Class II 2003-10-10
K033043 MODIFICATION TO HL168 Health & Life Co., Ltd. DXN Class II 2003-10-10
K031760 VIEWPOINT TELEMETRY SYSTEM Datascope Corp. MHX Class II 2003-10-10
K032837 HL888BM Health & Life Co., Ltd. DXN Class II 2003-10-10
K031863 CARESTATION 126S VIDEOPHONE Motion Media Technology, Inc. MWI Class II 2003-10-10
K031840 CAREMATIX WELLNESS SYSTEM Carematix, Inc. DXN Class II 2003-10-10
K032839 HL888BA Health & Life Co., Ltd. DXN Class II 2003-10-10
K032411 JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE Js Vascular, Inc. DQX Class II 2003-10-07
K030279 REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp. NLH Class II 2003-10-03
K032736 HEART 2006 Aerotel Medical Systems (1998) , Ltd. DXH Class II 2003-10-03
K032200 ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH Remco Italia S.P.A. DPS Class II 2003-10-03

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