meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
1992-12-03

Clearances · page 129 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K915736 MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING Medtronic Vascular DTB Class III 1992-12-03
K922484 COBE SAMPLING SITE Cobe Cardiovascular, Inc. DQO Class II 1992-12-03
K922933 SORIN MONOLYRH INTEGRATED MEMBRANE LUNG Sorin Biomedica, Fiat, USA, Inc. DTZ Class II 1992-11-30
K925679 VENA CAVA FILTER SYSTEMS, MODIFICATION B. Braun Vena-Tech DTK Class II 1992-11-27
K924360 IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) Impra, Inc. DYF Class II 1992-11-25
K921659 ULTRA LOW POROSITY DACRON WOVEN PATCH Intervascular, Inc. DXZ Class II 1992-11-25
K922905 FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1992-11-24
K920707 HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER Devices For Vascular Intervention, Inc. MCW Class II 1992-11-23
K922182 UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492 Medtronic Vascular LDF Class II 1992-11-23
K922404 TUBE GRIP Georgia Medical Products, Inc. KRI Class I 1992-11-23
K922268 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491 Medtronic Vascular LDF Class II 1992-11-23
K922269 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 The Heart Valve Div. Medtronic Cardiovascular Surg LDF Class II 1992-11-23
K924202 RADIFOCUS(R) (CATHETER) GUIDE WIRE Terumo Medical Corp. DQX Class II 1992-11-23
K921216 OFF-LINE ANALYSIS SYSTEM Softheart, Inc. DQK Class II 1992-11-20
K924210 NAMTAI ELECTRONIC BLOOD PRESSURE METER Nam Tai Electronics (Canada) , Ltd. DXN Class II 1992-11-20
K922610 BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1992-11-18
K924491 INTRODUCER, PERCUTANEOUS -- MODIFICATION Medamicus, Inc. DYB Class II 1992-11-18
K922105 USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING C.R. Bard, Inc. DQO Class II 1992-11-17
K922912 SEEKER LITE - 10 Target Therapeutics DQX Class II 1992-11-17
K924276 SHORT TEGWIRE -- MODIFIED Boston Scientific Corp LIT Class II 1992-11-10
K922927 MORTARA INSTRUMENT ST CENTRAL STATION Mortara Instrument, Inc. DPS Class II 1992-11-10
K921845 INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT Becton Dickinson Vascular Access, Inc. DQO Class II 1992-11-10
K921194 HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING Hewlett-Packard Co. DRT Class II 1992-11-09
K911529 BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG Lead-Lok, Inc. DRX Class II 1992-11-09
K911518 BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM Lead-Lok, Inc. DRX Class II 1992-11-09
K924009 INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard DQX Class II 1992-11-06
K914765 SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS Siemens Medical Electronics DXN Class II 1992-11-06
K922291 PERSONAL 120/210 LAPTOP STRESS OPTION Biosound, Inc. DPS Class II 1992-11-04
K922075 AVOXIMETER A-Vox Systems, Inc. DQA Class II 1992-11-04
K921895 TISSUE PATCH, TISSUE GRAFT Bio-Vascular, Inc. DXZ Class II 1992-11-04
K923327 STETHOSCOPE COVER Anup Chakraborty Co. LDE Class I 1992-11-03
K921627 DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101 Showa Engineering Co., Ltd. DXN Class II 1992-11-03
K924047 SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1992-11-02
K921898 TAD MODEL #9655 Loric Technology DRS Class II 1992-11-02
K924133 ELECTROTRACE, MODIFICATION Jason Marketing Co. DRX Class II 1992-10-30
K915580 BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP Belmont Instrument Corp. DSP Class II 1992-10-30
K920601 ASTRA T2, ASTRA T4, ASTRA T6 Cardiac Pacemakers, Inc. DXY Class III 1992-10-28
K923134 CORDIS STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1992-10-26
K921519 OXICOM-2100 Waters Instruments, Inc. DQA Class II 1992-10-23
K923826 PARAMETRIC PROCESS CONTROL Scimed Life Systems, Inc. LIT Class II 1992-10-22
K913042 MODIFICATIONS TO SERIES OF CARDIAC CATHETERS Sentron, Inc. DXO Class II 1992-10-21
K921401 BIOPSY FORCEPS Annex Medical, Inc. DWZ Class II 1992-10-21
K920009 3M LITTMANN GRAPHIC DISPLAY SYSTEM 3M Health Care, Ltd. DQD Class II 1992-10-21
K923930 ELECTROCARDIOGRAPH TRANSMITTER Tz Medical, Inc. DXH Class II 1992-10-21
K924095 TIMEOSCOPE AND FLEXISCOPE Stethoscopes of America, Inc. LDE Class I 1992-10-20
K923407 MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES Medtronic Vascular LDF Class II 1992-10-19
K920774 MVR COLLAPSIBLE VENOUS RESERVOIR BAG Medtronic Vascular DTN Class II 1992-10-19
K921577 SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER Scimed Life Systems, Inc. LIT Class II 1992-10-16
K920824 ROADRUNNER RLTF GUIDE WIRE Cook, Inc. DQX Class II 1992-10-16
K920984 KING OF HEARTS EXPRESS (E.X.) MONITOR Instromedix, Inc. DXH Class II 1992-10-14
K921207 DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION Physiometrix, Inc. DRX Class II 1992-10-13
K921074 BP PUMP Bio-Tek Instruments, Inc. DXN Class II 1992-10-09
K912815 NIBP 9225 COMBI S & W Medico Teknik DXN Class II 1992-10-09
K920907 OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO Teleflexmedical, Inc. DYB Class II 1992-10-06
K923480 SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA Scimed Life Systems, Inc. DQO Class II 1992-10-06
K920908 OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1 Teleflexmedical, Inc. DYB Class II 1992-10-06
K922058 MODELS M1175A AND M1176A COMPONENT MONITORING SYST Hewlett-Packard Co. MHX Class II 1992-10-06
K923864 BATTERY PACK Portable Power Systems, Inc. LDD Class II 1992-10-05
K920312 NEW COBE CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. DTN Class II 1992-10-01
K921014 MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR Hewlett-Packard Co. MHX Class II 1992-10-01
K923682 MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE Hewlett-Packard Co. DQA Class II 1992-09-28
K921399 OCCLUSION BALLON CATHETER MODIFICAION Interventional Therapeutics Corp. DXC Class II 1992-09-25
K923240 BAXTER SENSOR CORONARY GUIDEWIRE Baxter Healthcare Corp DQX Class II 1992-09-23
K923493 LIFE-TEL T.R.S. Raco Products Co. DXH Class II 1992-09-23
K922025 ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF Pioneering Technologies, Inc. DSY Class II 1992-09-22
K915468 MODEL P-81 CRITIKON PRINTER Critkon, Inc. DXN Class II 1992-09-22
K921702 MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI Merit Medical Systems, Inc. DQX Class II 1992-09-21
K915726 PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH Baxter Healthcare Corp DQO Class II 1992-09-21
K921929 GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) General Devices DXH Class II 1992-09-18
K923311 CONDUCER HEAT EXCHANGER 3M Health Care, Sarns DTR Class II 1992-09-18
K922992 CONDUCER CARDIOPLEGIA SET SITH MP4 3M Health Care, Ltd. DWF Class II 1992-09-18
K923297 MODEL #340 STEALTH-TRODE+LS Cardiotronics, Inc. LDD Class II 1992-09-18
K921310 CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER Cordis Corp. DQO Class II 1992-09-17
K914979 EDM(R) INFUSION CATHETER Peripheral Systems Group KRA Class II 1992-09-16
K921500 CENTRI-SAFE(TM) VALVE Cardio Systems, Inc. MJJ Class II 1992-09-15
K920889 MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS Medtronic Vascular DTZ Class II 1992-09-15
K915188 MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD Cook Pacemaker Corp. DTB Class III 1992-09-11
K921311 CORDIS SHUTTLE CATHETER W/ SIDEHOLES Cordis Corp. DQY Class II 1992-09-09
K914260 4240 DYNAMIC BP/HEART RATE MONITOR Suntech Medical Instruments, Inc. DXN Class II 1992-09-04
K920743 DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS Nihon Kohden America, Inc. DSI Class II 1992-09-03
K915737 AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR Electromedics, Inc. DTN Class II 1992-09-03
K922254 LUKENS 2-0 BRAIDED SILK SUTURES Quinton, Inc. DQO Class II 1992-09-01
K924110 LEOCOR CORFLO PUMP -- MODIFICATION Leocor, Inc. DQI Class II 1992-09-01
K920308 COWBOY II Kinetic Concepts, Inc. JOW Class II 1992-08-24
K920980 USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT C.R. Bard, Inc. DQO Class II 1992-08-24
K912664 TEC ROTATING DUAL HEMOVALVE Intensive Technology, Inc. DYB Class II 1992-08-24
K920884 GUIDEWIRES, VARIOUS TYPES Acme-Monaco Corp. DQX Class II 1992-08-19
K920295 MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) Oxford Medilog, Inc. DQK Class II 1992-08-18
K914489 NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING Telectronics Pacing Systems, Inc. DTB Class III 1992-08-17
K915347 SCIMED VIPER CATHETER Scimed LIT Class II 1992-08-17
K923398 CPI MODEL 2215 Seamed Corp. DTE Class II 1992-08-14
K920528 CATHETER INTRODUCER Boston Scientific Corp DYB Class II 1992-08-12
K921719 ACS ANGIOTRAK(TM) SYSTEM Advanced Cardiovascular Systems, Inc. MAV Class II 1992-08-07
K921165 BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 Augustine Medical, Inc. DWJ Class II 1992-08-06
K912270 POLYCATH #WMC-900 Worldwide Medical DQO Class II 1992-08-05
K921318 ADAPTING SLEEVE KIT MODEL 4023 Siemens-Pacesetter, Inc. DTD Class II 1992-08-03
K913624 MEDRAD MCT-PLUS INJECTOR Medrad, Inc. DXT Class II 1992-07-30
K915757 MODELS M1722A, M1723A, M1724A DEFIBRILLATORS Hewlett-Packard Co. DRO Class II 1992-07-30
K922563 LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) Raco Products Co. LDD Class II 1992-07-28
K915268 CATHETER TWO STAGE VENOUS RETURN Dlp, Inc. DWF Class II 1992-07-27

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