meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
51
Latest Decision
1996-05-02

Clearances · page 117 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960806 TURBO TRACKER Target Therapeutics DQO Class II 1996-05-02
K961135 INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) C.R. Bard, Inc. DYB Class II 1996-04-30
K960563 SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES Scimed Life Systems, Inc. DQX Class II 1996-04-29
K960657 SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1996-04-29
K954552 RAILWIRE Boston Scientific /International Technologies DQX Class II 1996-04-29
K960923 CARBOMEDICS MITRAL ROTATOR Carbomedics, Inc. MOP Class I 1996-04-29
K954622 IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK Boston Scientific /International Technologies DQX Class II 1996-04-29
K960706 VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT Carbomedics, Inc. DSY Class II 1996-04-25
K960379 ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE Heart Technology Mfg., Inc. MCW Class II 1996-04-25
K960166 PERCOR STAT-DL 9.5 FR. 34 & 40CC Datascope Corp. DSP Class II 1996-04-24
K954495 PACETRAK PLUS Universal Medical, Inc. DXH Class II 1996-04-22
K952879 SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT Baxter Healthcare Corp KFM Class II 1996-04-22
K960139 G.E. STERILE ANGIOGRAPHIC TRAY GE Medical Systems DWS Class I 1996-04-19
K953904 SARNS 9000 UNIVERSAL ROLLER PUMP 3M Health Care, Ltd. DWB Class II 1996-04-19
K960312 RDI CARDIAC INSULATION PAD R D Intl. DWP Class II 1996-04-19
K953901 SARNS 800 ROLLER PUMP 3M Health Care, Sarns DWB Class II 1996-04-19
K950688 OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM Safety Tek Corp. DRT Class II 1996-04-18
K953522 USCI IDEAL PTCA KIT Ryder Intl. Corp. MAV Class II 1996-04-17
K960144 G.E. STERILE CT BIOPSY TRAY GE Medical Systems DWS Class I 1996-04-15
K953185 PLATINUM SERIES EP DIAGNOSTIC CATHETERS Medtronic Cardiorhythm DRF Class II 1996-04-15
K960169 CARBOMEDICS VALVE TESTER Carbomedics, Inc. DTJ Class I 1996-04-15
K960542 NOGA Biosense, Ltd. DRF Class II 1996-04-15
K960406 BRAUN HEMOSTASIS INTRODUCERS B.Braun Medical, Inc. DYB Class II 1996-04-12
K954760 LMI ARTERIAL EMBOLECTOMY CATHETER Lucas Medical, Inc. DXE Class II 1996-04-11
K960264 CONMED EKG STRIPPER Conmedcorp DRX Class II 1996-04-09
K960501 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1996-04-09
K955135 0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING Biocompatibles , Ltd. DQX Class II 1996-04-09
K960517 BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER C.R. Bard, Inc. LIT Class II 1996-04-09
K960143 G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY GE Medical Systems DWS Class I 1996-04-09
K955060 ACCELERATED TRANSMISSION PROTOCOL Instromedix, Inc. DXH Class II 1996-04-08
K954906 FIRST PICC INTRODUCER CATHETER Becton Dickinson Vascular Access, Inc. DYB Class II 1996-04-08
K955175 ACS ANCHOR EXCHANGE DEVICE Advanced Cardiovascular Systems, Inc. DQX Class II 1996-04-05
K935732 CARDIO PERFECT ST 2001 Cardio Control BV DSI Class II 1996-04-04
K960975 1-4F INFINITI ANGIOGRAPHIC CATHETER Cordis Corp. DQO Class II 1996-04-02
K960070 NUMED ATRIOSEPTOSTOMY CATHETER NuMED, Inc. DQO Class II 1996-04-02
K960801 SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) North American Instrument Corp. DQO Class II 1996-03-29
K954397 BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY Koven Technology, Inc. DPW Class II 1996-03-29
K953676 BREEZE DIGITAL INFLATION DEVICE Namic MAV Class II 1996-03-29
K954692 CPR PROMPT County Line , Ltd. LIX Class II 1996-03-27
K951448 GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE Global Medical Products, Ltd. DRC Class II 1996-03-27
K960098 RMI INTERNAL MAMMARY ARTERY CANNULA Research Medical, Inc. DQR Class II 1996-03-26
K953945 RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET Dlp, Inc. DWF Class II 1996-03-26
K955818 FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER Quest Medical, Inc. DWF Class II 1996-03-26
K960251 COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR Aristo Medical Products, Inc. DQA Class II 1996-03-26
K951722 PERCEPTOR COMPENSATOR MORSE MANIFOLD Namic DRS Class II 1996-03-25
K955817 CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER Cordis Webster, Inc. DRF Class II 1996-03-25
K955820 BRAUN HEMOSTASIS INTRODUCERS B.Braun Medical, Inc. DYB Class II 1996-03-25
K955869 SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE Scimed Life Systems, Inc. MAV Class II 1996-03-22
K951832 LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433 Vasamedics, LLC DPT Class II 1996-03-21
K955015 ZYMED HOLTER SCANNER MODEL 2010 Zymed Medical Instrumentation DQK Class II 1996-03-18
K953835 LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR Dideco S.R.L. DTZ Class II 1996-03-15
K955722 FLEXON TEMPORARY CARDIAC PACER LEAD Davis & Geck, Inc. LDF Class II 1996-03-15
K951193 CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 Tycos Instruments, Inc. DXN Class II 1996-03-13
K955785 TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET C.R. Bard, Inc. DYB Class II 1996-03-12
K955532 DIASTAT VASCULAR ACCESS GRAFT W. L. Gore & Associates, Inc. DSY Class II 1996-03-11
K953750 CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Boston Scientific Corp DRF Class II 1996-03-11
K955125 LMI OCCLUSION CATHETER Lucas Medical, Inc. DXE Class II 1996-03-11
K955637 ESSENCE GUIDEWIRE Cordis Neurovascular, Inc. DQX Class II 1996-03-11
K955886 MEGA PTA BALLOON CATHETER Cordis Corp. LIT Class II 1996-03-11
K955417 VITAL PAK Vital Signs, Inc. DXG Class II 1996-03-08
K953821 BIOCOR 200 HARDSHELL VENOUS RESERVIOR Minntech Corp. DTN Class II 1996-03-07
K955588 VASCUTEK GRAFT SIZER SET Carbomedics, Inc. DSY Class II 1996-03-07
K953838 MYOCARDIAL PROTECTION SYSTEM Quest Medical, Inc. DTR Class II 1996-03-06
K945627 PIKOS LP 01, PIKOS LP E01 Biotronik, Inc. DXY Class III 1996-03-04
K953850 REDOX Kinetic Concepts, Inc. JOW Class II 1996-03-04
K955554 HEMO-VALVE North American Instrument Corp. DTL Class II 1996-03-04
K950537 CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH Cardiophonics, Inc. DQC Class I 1996-03-01
K953127 ACCUSTRESS EXERCISE TESTING SYSTEM Hewlett-Packard Co. DQK Class II 1996-02-29
K950018 CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM Cambridge Heart, Inc. DPS Class II 1996-02-29
K942530 ART-ASSIST MODEL AA-1000 Aci Medical, Inc. JOW Class II 1996-02-28
K955499 LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER Lucas Medical, Inc. MJN Class II 1996-02-28
K955551 CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 Cardio Metrics, Inc. DQX Class II 1996-02-28
K954719 INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1996-02-27
K953133 SCIMED DISPATCH CORONARY INFUSION CATHETER Scimed Life Systems, Inc. KRA Class II 1996-02-23
K955485 BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS B.Braun Medical, Inc. DQO Class II 1996-02-23
K955152 STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER Stoeckert Instrumente DTW Class II 1996-02-22
K954489 TRINITY SLEEVE(S) Delphi Consulting Group JOW Class II 1996-02-22
K952884 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1996-02-21
K955038 STOCKERT S3 DOUBLE HEAD PUMP MODULE Stoeckert Instrumente DWB Class II 1996-02-21
K955381 B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT B.Braun Medical, Inc. DXT Class II 1996-02-21
K955349 HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC Meadox Medicals, Div. Boston Scientific Corp. DXZ Class II 1996-02-14
K942852 RESPITRACE PT Non-Invasive Monitoring Systems, Inc. DQK Class II 1996-02-13
K942771 RESPIEVENTS Non-Invasive Monitoring Systems, Inc. DQK Class II 1996-02-13
K953648 A-V IMPULSE SYSTEM MODEL 6060 Novamedix , Ltd. JOW Class II 1996-02-12
K954284 MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) Medi-Plast Intl., Inc. DTL Class II 1996-02-12
K950723 AMBULATORY (HOLTER) RECORDING SYSTEM Biosensor Corp. DQK Class II 1996-02-09
K955396 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM Boston Scientific Corp DTK Class II 1996-02-09
K955230 VASCUTEK GELSOFT PLUS VASCULAR GRAFT Vascutek, Ltd. DSY Class II 1996-02-09
K953298 MS CLASSIQUE BALLOON DIATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1996-02-08
K960310 EPIC INTRODUCER SHEATH North American Instrument Corp. DYB Class II 1996-02-07
K954388 CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE Conmedcorp DRX Class II 1996-02-06
K955293 FIBERED PLATINUM COIL, .035 TYPE Target Therapeutics KRD Class II 1996-02-06
K954282 ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG Statcorp, Inc. DXQ Class II 1996-02-06
K955801 RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD Terumo Medical Corp. DQX Class II 1996-02-02
K953564 MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE Medtronic Cardiac Surgery, Medtronic, Inc. DTL Class II 1996-02-02
K954714 AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) Pacesetter, Inc. DTB Class III 1996-02-01
K954848 HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. MAL Class II 1996-02-01
K955111 MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER Adam Spence Corp. DQO Class II 1996-01-31
K945215 MARS DIGITAL BLOOD PRESSURE MONITOR Mars Metal Co., Ltd. DXN Class II 1996-01-31
K943803 JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM Janus Biomedical, Inc. DTQ Class II 1996-01-30

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