meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
2000-08-18

Clearances · page 102 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K002209 GE MARQUETTE ECG ANALYSIS PROGRAM General Electric Medical Systems Information Techn MHX Class II 2000-08-18
K001969 GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 Medtronic Vascular DQY Class II 2000-08-16
K993698 SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX Mogul Enterprises DRF Class II 2000-08-16
K993934 V QUICK PATCH Vq Corp. DRX Class II 2000-08-15
K993875 BMT ANSCORE HEALTH MANAGEMENT SYSTEM Boston Medical Technologies, Inc. DPS Class II 2000-08-11
K001565 STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB Edwards Lifesciences, LLC DWF Class II 2000-08-10
K001091 CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 Next Millennium Software Solutions, Inc. DXH Class II 2000-08-10
K001492 QUINTON Q-STRESS, MODEL 000483 Quinton, Inc. DPS Class II 2000-08-09
K002118 STOCKERT COMPACT SYSTEM VERSION 2.0 Stoeckert Instrumente DTQ Class II 2000-08-09
K002116 S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 Medical Device Consultants, Inc. DTQ Class II 2000-08-09
K993913 TRUE Infinity Extrusion & Engineering, Inc. LIT Class II 2000-08-09
K993788 R.TEST EVOLUTION Novacor Div. MLO Class II 2000-08-04
K002212 MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 Micro Therapeutics, Inc. DQX Class II 2000-08-03
K994155 EXCELSIOR 1018 MICROCATHETER Boston Scientific, Target KRA Class II 2000-08-03
K001662 CHASE CARDIOVASCULAR PATCH Chase Medical, Inc. DXZ Class II 2000-08-02
K002009 HP M2376A DEVICE LINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. MWI Class II 2000-08-02
K001736 GALEO HYDRO AND GALEO HYDRO J-TIP Biotronik, Inc. DQX Class II 2000-08-02
K001182 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 Microlife Corp. DXN Class II 2000-08-01
K000737 COAXIAL DILATOR SET Xentek Medical, Inc. DRE Class II 2000-08-01
K001388 DATA MASTER PERFUSION MONITORING SYSTEM Dideco DRY Class II 2000-07-28
K001349 CARDIOVISE ECG INTERPRETATIVE SOFTWARE Inovise Medical, Inc. MWJ Class II 2000-07-27
K001369 RESPIEVENTS, VERSION 4.2 Non-Invasive Monitoring Systems, Inc. DQK Class II 2000-07-26
K002115 A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS A&D Engineering, Inc. DXN Class II 2000-07-25
K994141 CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 Medtronic Ave, Inc. MJN Class II 2000-07-21
K001317 ARIA Del Mar Medical Systems, LLC MWJ Class II 2000-07-21
K001390 BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES Biosense Webster, Inc. DSA Class II 2000-07-21
K002046 MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 Vsm Technology, Inc. DXN Class II 2000-07-21
K001930 MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 Nonin Medical, Inc. DQA Class II 2000-07-20
K001087 PTA BALLOON CATHETER Cook, Inc. LIT Class II 2000-07-20
K993205 BOOKER BOX, MODEL PAD 5010 Tz Medical, Inc. LDD Class II 2000-07-20
K001966 REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND Micro Therapeutics, Inc. KRA Class II 2000-07-20
K001306 STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX Andromed, Inc. DQD Class II 2000-07-20
K001288 DR180-II North East Monitoring, Inc. MWJ Class II 2000-07-20
K001359 DASH 3000/4000 PATIENT MONITOR General Electric Medical Systems Information Techn DSI Class II 2000-07-18
K001268 GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS General Electric Medical Systems Information Techn MHX Class II 2000-07-17
K001265 WELCH ALLYN INSTRUMENT INTERFACE MODULE Welch Allyn, Inc. MWI Class II 2000-07-13
K000647 DATEX-OHMEDA NETWORK AND CENTRAL Datex-Ohmeda, Inc. MSX Class II 2000-07-13
K001804 NUMED Z-5 ATRIOSEPTOSTOMY CATHETER NuMED, Inc. DXF Class II 2000-07-12
K993248 AMPLATZER SIZING BALLOON Aga Medical Corp. MJN Class II 2000-07-12
K001371 CARDEON ASCENDING BALLOON CANNULA (ABC) Cardeon Corp. DWF Class II 2000-07-07
K000062 CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT Cordis Corp. DTK Class II 2000-07-07
K001063 SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 Baxter Healthcare Corp DYG Class II 2000-07-07
K001251 SNIPER, MODEL OR-3872XX SERIES Nipro Medical Corp. DQX Class II 2000-07-07
K994032 FLUORO-TEX CARDIOVASCULAR PATCH Bridger Biomed, Inc. DXZ Class II 2000-07-07
K001822 THE V-BAG Circulatory Technology, Inc. DTN Class II 2000-07-07
K001770 BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A Bci, Inc. DQA Class II 2000-07-05
K001135 6F & 7F INTRODUCING CATHETERS (MODIFICATION) Cordis Corp. DYB Class II 2000-07-03
K001848 OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 Omron Healthcare, Inc. DXN Class II 2000-07-03
K001670 AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 Omron Healthcare, Inc. DXN Class II 2000-06-30
K001081 BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 Cardiodynamics International Corp. DSB Class II 2000-06-30
K001664 COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 Agilent Technologies, Inc. MHX Class II 2000-06-30
K001688 DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER Datex-Ohmeda, Inc. DQA Class II 2000-06-30
K001722 AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE Agilent Technologies Deutschland GmbH MHX Class II 2000-06-30
K001787 QUART ARTERIAL FILTER, MODEL HBF 140 Jostra Medizintechnik AG DTM Class II 2000-06-30
K001776 MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. MWI Class II 2000-06-30
K001671 ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 Omron Healthcare, Inc. DXN Class II 2000-06-30
K001305 MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM General Electric Medical Systems Information Techn DQK Class II 2000-06-27
K001180 TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 Pace Medical DTE Class II 2000-06-27
K993623 GEMINI E Allen Medical Instruments Corp. DQD Class II 2000-06-23
K991038 VASO PRESS DVT SYSTEM, MODELS VP500, VP501 Britt Corp., Inc. JOW Class II 2000-06-22
K001592 ECHOCOM, IMAGECOM, DOKUCOM Tomtec Imaging Systems GmbH DQK Class II 2000-06-16
K000955 PLACER MODEL 6232 STEERABLE STYLET Medtronic Vascular DRB Class II 2000-06-16
K000313 TEARAWAY INTRODUCER SHEATH Xentek Medical, Inc. DYB Class II 2000-06-16
K994209 STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP Cobe Cardiovascular, Inc. DWF Class II 2000-06-14
K001112 GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC General Electric Medical Systems Information Techn DXJ Class II 2000-06-14
K001762 PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM Pulsion Medical Systems, Inc. DXG Class II 2000-06-13
K000237 EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION Cybercare, Inc. DXN Class II 2000-06-13
K001034 MODEL APS ALTERNANS PROCESSING SYSTEM Cambridge Heart, Inc. DPS Class II 2000-06-09
K993316 UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE Ueda Avancer Corp. DXN Class II 2000-06-09
K001602 DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) Dideco S.P.A. DTN Class II 2000-06-08
K001546 ALLON 2001 Mtre Advanced Technology , Ltd. DWJ Class II 2000-06-08
K000798 TALON BALLOON DILATION CATHETER Boston Scientific Corp LIT Class II 2000-06-08
K991137 ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER Minntech Corp. DTR Class II 2000-06-08
K992980 ENGAGE JAW INSERTS Novare Surgical Systems, Inc. DXC Class II 2000-06-08
K000815 AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) Datex-Ohmeda MHX Class II 2000-06-08
K992932 CIPA (ADULTS) CIPI (INFANTS) Dmc Medical, Ltd. DWF Class II 2000-06-07
K001437 ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. DQK Class II 2000-06-07
K001454 SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D Micro Therapeutics, Inc. DQX Class II 2000-06-07
K001436 AGILENT M2636A TELEMON MONITOR Agilent Technologies, Inc. DSI Class II 2000-06-07
K000831 STAT-SHELL DISPOSABLE SP02 SENSOR Epic Medical Equipment Services, Inc. DQA Class II 2000-06-05
K993772 X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR Terumo Medical Corp. DTZ Class II 2000-06-05
K000882 DATEX-OHMEDA CS/3 TELEMETRY SYSTEM Datex-Ohmeda MHX Class II 2000-06-05
K000820 AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 Endosonics Corp. DQO Class II 2000-06-05
K001435 VIKING OPTIMA GUIDING CATHETER Guidant Corp. DQY Class II 2000-06-02
K001413 ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 Biotronik, Inc. DTB Class III 2000-06-02
K991103 MODIFICATION TO ACIST CL 100H Acist Medical Systems DXT Class II 2000-05-31
K984231 ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B Invasatec DXT Class II 2000-05-31
K001367 FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX St. Jude Medical, Inc. DYB Class II 2000-05-31
K992668 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) Innerdyne, Inc. DYB Class II 2000-05-26
K000500 DINAMAP ADVANCED NIBP MODULE Critikon Company, LLC DXN Class II 2000-05-26
K000645 GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 General Electric Medical Systems Information Techn DPS Class II 2000-05-24
K001346 ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX St. Jude Medical, Inc. DYB Class II 2000-05-24
K000609 CARDTEL, MODEL NT-100 Cardiac Telecommunications MWJ Class II 2000-05-23
K993758 PROAIR 3000 COMPRESSION SYSTEM Medical Compression Systems (Dbn) , Ltd. JOW Class II 2000-05-19
K000729 ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL Arrow Intl., Inc. DSP Class II 2000-05-19
K001237 EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO Micro Therapeutics, Inc. MJN Class II 2000-05-18
K000779 APEXPRO TELEMETRY SYSTEM General Electric Medical Systems Information Techn DSI Class II 2000-05-18
K992543 HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE Hewlett-Packard Co. MKJ Class III 2000-05-18
K992320 MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Boston Scientific Corp LIT Class II 2000-05-18
K001333 AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI Agilent Technologies Deutschland GmbH DSI Class II 2000-05-17

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