meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
1994-02-01

Clearances · page 125 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932933 GC IV CORONARY GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1994-02-01
K925049 QUEST HEART INSULATION PAD Quest Medical, Inc. DWF Class II 1994-02-01
K930069 BIPOLAR BALLOON PACING CATHETER BY J-LLOYD J-Lloyd Medical, Inc. LDF Class II 1994-01-28
K935501 SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING Scimed Peripheral Interventions LIT Class II 1994-01-27
K933590 BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT Baxter Healthcare Corp DSY Class II 1994-01-26
K933334 MAGIC TORQUE GUIDEWIRE Boston Scientific Corp DQX Class II 1994-01-26
K935872 NAMTAI Nam Tai Electronics (Canada) , Ltd. DXN Class II 1994-01-24
K934742 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT Baxter Healthcare Corp DYG Class II 1994-01-24
K934901 TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc. DYB Class II 1994-01-21
K934378 SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Scimed Life Systems, Inc. LIT Class II 1994-01-18
K933603 LEADWIRE Sentry Medical Products, Inc. DSA Class II 1994-01-18
K935022 SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION Scimed Life Systems, Inc. DQX Class II 1994-01-18
K935817 MEDSIM 300 PATIENT SIMULATOR Dynatech/Nevada, Inc. DRT Class II 1994-01-18
K934988 9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER Scimed Life Systems, Inc. DQY Class II 1994-01-14
K925297 RI-MED Rudolf Riester GmbH & Co. KG DXQ Class II 1994-01-14
K934887 9750 ATHENA ETHERNET OPTION S & W Medico Teknik A/S DXK Class II 1994-01-14
K923664 SCOLE 300 ECG RECORDER Scole Engineering Co. DSH Class II 1994-01-13
K934009 ACS POWERGUIDE CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1994-01-11
K934727 REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER Cardiac Pacemakers, Inc. DWS Class I 1994-01-10
K934411 MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1994-01-07
K933235 CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF Cordis Corp. DWZ Class II 1994-01-06
K934793 SCIMED MAVERICK Scimed Peripheral Interventions LIT Class II 1994-01-05
K935652 NAMTAI Nam Tai Electronics (Canada) , Ltd. DXN Class II 1993-12-29
K932954 AVOXIMETER A-Vox Systems, Inc. DQK Class II 1993-12-27
K933236 CORDIS OPTA 5(TM), MODIFICATION Cordis Corp. LIT Class II 1993-12-27
K932704 PATIENT CABLE Sentry Medical Products, Inc. DSA Class II 1993-12-27
K931009 TYSHAK PERIPHERAL BALLOON DILATION CATHETER NuMED, Inc. LIT Class II 1993-12-21
K932800 CARDIMA TRACKER(R) INFUSION CATHETER Cardima, Inc. KRA Class II 1993-12-21
K924109 STEEROCATH II Ep Technologies, Inc. DRF Class II 1993-12-16
K926219 516YT DISPLAY DRIVER Vidco, Inc. DXJ Class II 1993-12-16
K935674 LIFEPAK 9 DEFIBRILLATOR/MONITOR Physio-Control Corp. LDD Class II 1993-12-16
K924108 TRACFINDER II Ep Technologies, Inc. DRF Class II 1993-12-16
K934602 ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1993-12-16
K932083 XDCS-100 Microwave Medical Systems, Inc. DXT Class II 1993-12-16
K932616 SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER Scimed Life Systems, Inc. KRA Class II 1993-12-15
K932268 MODIFICATIONS TO INTRA-AORTIC BALLOONS Kontron Instruments, Inc. DSP Class II 1993-12-15
K934951 VALVE SIZER Carbomedics, Inc. DTI Class I 1993-12-10
K934191 NEW BLUE MAX BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1993-12-09
K934433 VANTAGE DIALTAION CATHETER Peripheral Systems Group LIT Class II 1993-12-09
K934339 LOC GUIDE WIRE EXTENSION Advanced Cardiovascular Systems, Inc. DQX Class II 1993-12-09
K932537 SCIMED MAVERICK PTA CATHETER Scimed Life Systems, Inc. LIT Class II 1993-12-08
K934726 FEP RINGED GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DYF Class II 1993-12-08
K933943 FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS W. L. Gore & Associates, Inc. DSY Class II 1993-12-08
K932172 MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS Medtronic Vascular DTB Class III 1993-12-08
K932068 PERITEMP PF 4005 HEATER Perimed, Inc. DPW Class II 1993-12-07
K933977 AIRCAST EDEMAFLOW SYSTEM Aircast, Inc. JOW Class II 1993-12-07
K931629 CARAPACE ANGIOGRAPHY TRAYS Carapace, Inc. DQO Class II 1993-12-06
K926549 ENDOCATH ELECTROPHYSIOLOGY CATHETER Endo-Therapeutics, Inc. DRF Class II 1993-12-06
K924626 NOVAMETRIX MODEL 510 Novametrix Medical Systems, Inc. DQA Class II 1993-12-03
K932109 PROFILOMAT Qmed, Inc. DXN Class II 1993-12-03
K934660 R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211 R & D Batteries, Inc. DSH Class II 1993-12-03
K934355 ELECTROMEDICS BLOOD HEAT EXCHANGER Electromedics, Inc. DTR Class II 1993-12-03
K932438 MODEL IPM-1 IMPEDANCE PULSE MONITOR Electro-Diagnostic Instruments DSB Class II 1993-12-03
K934285 CATHETER INTRODUCER MODIFICATION Daig Corp. DYB Class II 1993-11-24
K934180 SLIMLINE 3000 Pymah Corp. DXQ Class II 1993-11-24
K920662 VASCOTWIST 9/60 Vascor Medical Corp. DTB Class III 1993-11-24
K931457 NDM SILVON ECG ELECTRODES Ndm Acquisition Corp. DRX Class II 1993-11-23
K934254 IMPULSE 3000 DEFIBRILLATOR ANALYZER Dynatech/Nevada, Inc. DRL Class II 1993-11-23
K934123 STOPCOCK (ONE-PORT MANIFOLD) Merit Medical Systems, Inc. DTL Class II 1993-11-23
K932252 AFFINITY HOLLOW FIBER OXYGENATOR Avecor Cardiovascular, Inc. DTZ Class II 1993-11-19
K930526 INTERMITTENT COMPRESSION SYSTEM MODEL 5000 Advanced Instruments, Inc. JOW Class II 1993-11-18
K934782 AMMEX TUBING ORGANIZER Ammex Cardiopulmonary Corp. KRI Class I 1993-11-18
K932851 DISPOSABLE PENILE BLOOD PRESSURE CUFFS D. E. Hokanson, Inc. DXQ Class II 1993-11-15
K931968 CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO 3M Health Care, Ltd. DRY Class II 1993-11-10
K924320 ULTRA THIN BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1993-11-10
K926467 COBE CMS-FS MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. DTZ Class II 1993-11-09
K932370 REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET Remington Medical, Inc. DYB Class II 1993-11-09
K932323 PERCUTANEOUS INTRODUCER Medamicus, Inc. DYB Class II 1993-11-09
K933764 LIFE-AIR 1000 PATIENT WARMING COVER Progressive Dynamics, Inc. DWJ Class II 1993-11-09
K926162 580CD DISPLAY DRIVER Vidco, Inc. DXJ Class II 1993-11-08
K926333 CPR PLUS Kells Medical, Inc. LIX Class II 1993-11-08
K934474 PILOT CARDIOVASCULAR SYSTEMS 2 CM PILOT WIRE Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard DQX Class II 1993-11-08
K932724 SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY Spacelabs Medical, Inc. DXJ Class II 1993-11-05
K923611 ULTRA THIN BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1993-11-04
K930081 OHMEDA ADAPTABLE CABLE W/DETACHABLE SENSOR Ohmeda Monitoring Systems DQO Class II 1993-11-04
K933700 DYE MANAGEMENT SYSTEM Abbott Laboratories DQO Class II 1993-11-03
K931743 BURRON CARDIOVASCULAR ANGESTAT(TM) B.Braun Medical, Inc. DYB Class II 1993-11-02
K933481 SORIN MONOLYTH VENOUS RESERVOIR Sorin Biomedical, Inc. DTN Class II 1993-11-02
K930894 MULTITRAK-PLUS Zymed Medical Instrumentation DSH Class II 1993-11-01
K924452 SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER Baxter Healthcare Corp DYG Class II 1993-10-29
K933204 BARD PTFE VASCULAR GRAFT C.R. Bard, Inc. DSY Class II 1993-10-27
K932188 SAFESET RESERVOIR Abbott Laboratories KRA Class II 1993-10-25
K932900 AIRCAST VENAFLOW SYSTEM Aircast, Inc. JOW Class II 1993-10-25
K930950 GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE W. L. Gore & Associates, Inc. DXZ Class II 1993-10-22
K933069 MODEL EP-2 CLINICAL STIMULATOR Ep Medical, Inc. DTA Class II 1993-10-21
K924388 ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD Angemed, Inc. LDF Class II 1993-10-21
K925638 PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 Baxter Healthcare Corp DXO Class II 1993-10-18
K931787 ZOLL PD 5300 Zoll Medical Corp LDD Class II 1993-10-15
K931489 INTHERM RADIALLY EXPANDING DILATING INTRODUCER Innerdyne Medical, Inc. DYB Class II 1993-10-15
K933496 MAXIMA FILTERED HARDSHELL RESERVIOR Medtronic Vascular DTP Class II 1993-10-15
K933517 AUTOMATIC PULL BACK DEVICE Cardiovascular Imaging Systems, Inc. DQX Class II 1993-10-15
K921377 P/METER Zertl Medical, Inc. DPW Class II 1993-10-12
K931804 ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO Zoll Medical Corp LDD Class II 1993-10-08
K931805 ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT Zoll Medical Corp LDD Class II 1993-10-08
K931803 5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES Zoll Medical Corp LDD Class II 1993-10-08
K932028 PD-1400 PACER/DEFIBRILLATOR Zoll Medical Corp MKJ Class III 1993-10-08
K934359 SCIMED STRIKE STEERABLE GUIDE WIRE Scimed Peripheral Interventions DQX Class II 1993-10-07
K934067 POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 National Custom Ent., Inc. DRK Class III 1993-10-07
K931903 SURELOCK(TM) SNAPLESS MONITORING ELECTRODE Ludlow Technical Products DRX Class II 1993-10-07
K932931 D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT Zoll Medical Corp MKJ Class III 1993-10-07

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