meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1994-06-07

Clearances · page 124 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K935077 CATH-SEAL Universal Medical Instrument Corp. DYB Class II 1994-06-07
K931794 MARINR SERIES EP DIAGNOSTIC CATHETERS Medtronic Cardiorhythm DRF Class II 1994-06-06
K933021 MODEL T131 MEMORY TRANSMITTER Biometric Products, Inc. DXH Class II 1994-06-06
K940816 BARD(R) EXPANDED PTFE VASCULAR GRAFT C.R. Bard, Inc. DSY Class II 1994-06-02
K941485 CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES Cardio Metrics, Inc. DQX Class II 1994-05-31
K936260 TRANSIT INFUSION CATHETER Cordis Corp. DQO Class II 1994-05-31
K931444 PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS Sorin Biomedica, Fiat, USA, Inc. DTZ Class II 1994-05-27
K940651 SARNS ULTRASONIC AIR SENSOR 3M Health Care, Sarns KRL Class II 1994-05-24
K941895 SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING Scimed Life Systems, Inc. DQX Class II 1994-05-24
K940795 SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER Baxter Edwards DYG Class II 1994-05-24
K936247 MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES Medicon Instruments, Inc. DRC Class II 1994-05-19
K930745 BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER B.Braun Medical, Inc. LIT Class II 1994-05-19
K940906 GORE-TEX CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. DXZ Class II 1994-05-18
K941811 HP M1175A, M1176A, COMPONENT MONITORING SYSTEM Hewlett-Packard Co. DPS Class II 1994-05-17
K933987 AOR-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1994-05-17
K934638 REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 Koven Technology, Inc. JOP Class II 1994-05-13
K941229 ONTRAC STEERABLE GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 1994-05-12
K935403 WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. DQO Class II 1994-05-12
K940036 ENDOSURG DISPOSABLE SECONDARY TROCAR Endosurg DRC Class II 1994-05-12
K934541 SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION Scimed Life Systems, Inc. DQO Class II 1994-05-12
K934899 BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM Telectronics Pacing Systems, Inc. DTD Class II 1994-05-12
K935717 AFFINITY VENOUS RESERVIOR BAG Avecor Cardiovascular, Inc. DTN Class II 1994-05-10
K940545 SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH Scimed Life Systems, Inc. DQY Class II 1994-05-06
K935590 EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR Ep Medical, Inc. JOQ Class II 1994-05-05
K935738 MEDTRONIC GCIII CORONARY GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1994-05-04
K940824 DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III W. L. Gore & Associates, Inc. DYF Class II 1994-05-04
K926298 520 DISPLAY DRIVER- STATUS I Vidco, Inc. DRT Class II 1994-05-04
K940559 ACS POWERBASE(TM) CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1994-05-03
K935404 FLOW DIRECTED THERMODILUTION BALLOON CATHETER J-Lloyd Medical, Inc. DYG Class II 1994-05-03
K925168 MISCELLANEOUS PACING LEAD Oscor Medical Corp. DTD Class II 1994-05-03
K940062 DIASTAT VASCULAR ACCESS GRAFT W. L. Gore & Associates, Inc. DSY Class II 1994-05-02
K933055 MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF Medtronic Vascular DTB Class III 1994-05-02
K932884 MINIX/MINIX ST PULSE GENERATORS Medtronic Vascular DXY Class III 1994-05-02
K935425 METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS Medtronics Interventional Vascular DQY Class II 1994-04-26
K935402 ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. DQO Class II 1994-04-26
K940578 MANUAL STETOSCOPE Bhs Intl., Inc. LDE Class I 1994-04-26
K930806 ZYMED HOLTER SCANNER MODEL 2010 Agilent Technologies DQK Class II 1994-04-25
K935763 SURGIPUMP W.O.M. World of Medicine GmbH DQI Class II 1994-04-21
K940603 SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER Scimed Life Systems, Inc. DQY Class II 1994-04-19
K941283 INNERSENSE DISPOSABLE MICROTRANSDUCER Becton Dickinson Vascular Access, Inc. DXO Class II 1994-04-19
K920790 MARQUETTE EAGLE MONITOR Marquette Electronics, Inc. DSI Class II 1994-04-19
K934763 SORIN BLOOD CARDIOPLEGIA SYSTEM Sorin Biomedical, Inc. DTN Class II 1994-04-15
K934847 NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS Sorin Biomedical, Inc. DTN Class II 1994-04-15
K934624 ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE Advanced Cardiovascular Systems, Inc. DYB Class II 1994-04-13
K920083 BIOCHEM MODEL 3302 NEWOX2 OXIMETER Biochem International, Inc. DQA Class II 1994-04-11
K934685 SOFTTOUCH GUIDE CATHETER Mallinckrodt Medical DQY Class II 1994-04-07
K921454 FUKUDA DENSHI MODEL HG-301 Fukuda Denshi USA, Inc. DQA Class II 1994-04-01
K934581 SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. DQO Class II 1994-03-31
K935170 CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS Lake Region Mfg., Inc. DQX Class II 1994-03-31
K940187 ENVOY GUIDING CATHETER Cordis Neurovascular, Inc. DQY Class II 1994-03-30
K926515 CARD GUARD MODEL CG-8000 Card Guard Scientific Survival , Ltd. DXH Class II 1994-03-30
K940063 MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS Medtronics Interventional Vascular LIT Class II 1994-03-29
K935111 UNIPOWERR RECHARGEABLE BATTERY PACK Unipower Corp. LDD Class II 1994-03-28
K936182 CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT Ohmeda Medical KRB Class II 1994-03-25
K925295 EXACTA-SPEZIAL Rudolf Riester GmbH & Co. KG DXN Class II 1994-03-25
K925813 DIAGNOSTIC INTRAVASCULAR CATHETER Target Therapeutics DQO Class II 1994-03-23
K936183 SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS Sorin Biomedical, Inc. DTN Class II 1994-03-23
K933084 CHECK VALVE (FITTING) Merit Medical Systems, Inc. DTL Class II 1994-03-23
K933498 EXTERNAL VEIN STRIPPER Applied Medical Resources DWX Class II 1994-03-23
K933731 MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD Medtronic Vascular DTB Class III 1994-03-21
K930314 HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE Aerotel, Ltd. DXH Class II 1994-03-18
K932863 E-FAX REMOTE MONITOR Coherent Systems, Inc. DXH Class II 1994-03-16
K922315 VITAL-COMBO(R) Physio-Control Corp. LDD Class II 1994-03-16
K934091 OXISAT Marquette Electronics, Inc. DQA Class II 1994-03-15
K936032 TORQUE DEVICE Merit Medical Systems, Inc. DQX Class II 1994-03-15
K930808 PROTECTOR INTRODUCER SHEATH Boston Scientific /International Technologies DYB Class II 1994-03-15
K922093 HASKEL CPR Haskel, Inc. DRM Class II 1994-03-14
K933012 MXT-2 12 LEAD MICRO-TRANSMITTER Medical Electronic Record Exchange DXH Class II 1994-03-14
K940463 NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS Nonin Medical, Inc. DQA Class II 1994-03-14
K931900 COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. Archival Technologies, Inc. DQK Class II 1994-03-11
K925485 VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER Vas-Cath, Inc. LIT Class II 1994-03-10
K935905 SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP Scimed Life Systems, Inc. DQX Class II 1994-03-10
K935929 MICROTRACK Devices For Vascular Intervention, Inc. MCW Class II 1994-03-10
K940171 CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM Cabot Medical Corp. DWJ Class II 1994-03-09
K931585 CORFAX CARDIAC DATA TRANSMITTER Ralin Medical, Inc. DXH Class II 1994-03-07
K935944 PROSCOPES AND ADSCOPES American Diagnostic Corp. LDE Class I 1994-03-03
K933713 VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT Baxter Healthcare Corp DTN Class II 1994-03-01
K933908 MEDRAD CT CUSTOM CONVENIENCE KIT Medrad, Inc. DXT Class II 1994-02-25
K932859 E-FAX RECEIVER Coherent Systems, Inc. DXH Class II 1994-02-24
K930982 ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE Cordis Corp. DQX Class II 1994-02-24
K925294 PRECISA Rudolf Riester GmbH & Co. KG DXN Class II 1994-02-23
K934127 SARNS LOW JETTING AORTIC ARCH CANNULA 3M Health Care, Sarns DWF Class II 1994-02-22
K935654 SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH Scimed Life Systems, Inc. DQO Class II 1994-02-22
K940214 STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF Statcorp, Inc. DXQ Class II 1994-02-22
K933649 CONMED ECG PATIENT CABLES AND LEADWIRES Conmedcorp DSA Class II 1994-02-18
K932823 BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK Portable Power Systems, Inc. DXN Class II 1994-02-17
K934439 RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR Portable Power Systems, Inc. DPS Class II 1994-02-17
K934015 RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB Portable Power Systems, Inc. LDD Class II 1994-02-17
K934508 BATTERY PACK# S1024NC Portable Power Systems, Inc. LDD Class II 1994-02-17
K933065 BATTERY PACK# S1009LA Portable Power Systems, Inc. DPS Class II 1994-02-17
K936286 ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) Gish Biomedical, Inc. DTN Class II 1994-02-14
K935577 SCIMED ENTRE II PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1994-02-14
K925283 VALVULOTOME Intramed Laboratories, Inc. MGZ Class II 1994-02-10
K930476 GUIDING CATHETER Boston Scientific Corp DQY Class II 1994-02-10
K934639 JOBST ATHROMBIC PUMP - SYSTEM 2500 Jobst Institute, Inc. JOW Class II 1994-02-09
K933404 CRITIKON CENTRAL STATIN MONITOR Critikon Company, LLC DPS Class II 1994-02-09
K933586 MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE Medtronic Vascular DTZ Class II 1994-02-07
K931716 BATTERY PACK 1017LA Portable Power Systems, Inc. DSI Class II 1994-02-07
K935977 SARNS AIR DETECTION SYSTEM 3M Health Care, Sarns KRL Class II 1994-02-04
K931266 BATTERY PACK #1012NC Portable Power Systems, Inc. LDD Class II 1994-02-03

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