meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1992-02-27

Clearances · page 131 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K912728 ALTAIR Diagnostic Medical Instruments DQK Class II 1992-02-27
K915421 GUIDEWIRE INTRODUCER SET B. Braun of America, Inc. DYB Class II 1992-02-27
K914531 STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES Arrow Intl., Inc. DQX Class II 1992-02-27
K914105 CATHWRITER(TM) Softheart, Inc. DQK Class II 1992-02-26
K913790 SENSORMEDICS OXYSHUTTLE II(TM) Sensor Medics Corp. DQA Class II 1992-02-26
K914109 PIKOS 01 & PIKOS E 01 Biotronik, GmbH & Co. DXY Class III 1992-02-26
K911646 NGM ESTP MODULE Datex Division Instrumentarium Corp. MHX Class II 1992-02-21
K912966 PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG Physio-Control Corp. LDD Class II 1992-02-21
K915337 CAPIOX LEVEL ALARM Terumo Medical Corp. DTW Class II 1992-02-21
K915553 USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING C.R. Bard, Inc. DYB Class II 1992-02-21
K915238 TRAC-WRIGHT TRAC 10 CATHETER Dow Corning Wright MCW Class II 1992-02-19
K915168 PROFLEX 5 Peripheral Systems Group LIT Class II 1992-02-19
K911184 SCANLAN/TAHERI VALVULOTOME Scanlan Intl., Inc. MGZ Class II 1992-02-18
K915724 MODEL 6984M LEAD EXTENDER KIT Medtronic Vascular DTD Class II 1992-02-18
K915760 MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG Corazonic Corp. DPS Class II 1992-02-14
K911835 RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM Gs Microsystems DSI Class II 1992-02-14
K915115 GUIDER DASHER Target Therapeutics DQX Class II 1992-02-14
K905175 PTI ANNULOPLASTY RING(STERILE) Pioneering Technologies, Inc. KRH Class II 1992-02-14
K915374 CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER Cordis Corp. DQY Class II 1992-02-14
K914032 NITINOL SEEKER(R) GUIDE WIRES Target Therapeutics DQX Class II 1992-02-11
K912464 PERMANENT CARDIAC PACING LEADS AND ADAPTORS Medtronic Vascular DTB Class III 1992-02-11
K914031 GUIDER-22 Target Therapeutics DQX Class II 1992-02-11
K915777 CORDIS SHUTTLE CATHETER Cordis Corp. DQY Class II 1992-02-11
K915836 CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS Cordis Corp. DQO Class II 1992-02-11
K915349 PTA BALLOON CATHETER Schneider Intl., Ltd. LIT Class II 1992-02-11
K915114 GUIDE WIRE EXTENSION Target Therapeutics DQX Class II 1992-02-11
K914030 GUIDER, DASHER Target Therapeutics DQX Class II 1992-02-11
K915364 CHRONOCOR VI MODEL 5012 Seamed Corp. DTE Class II 1992-02-07
K915224 CARDIOPHONICS MEMORY TRANSMITTER Rlt Medical Assoc., Inc. DXH Class II 1992-02-07
K915159 PEDIATRIC MULTI-FUNCTION ELECTRODES Zmi Corp. DRF Class II 1992-02-07
K914457 DISPOSABLE OPTICAL VALVULOTOME Nobles-Lai Engineering, Inc. MGZ Class II 1992-02-05
K912944 CT 8000 DIGITAL INJECTION SYSTEM Mallinckrodt Group, Inc. DXT Class II 1992-02-04
K912867 OSCOR MEDICAL CORP PERMANENT PACING LEAD Oscor Medical Corp. DTB Class III 1992-02-04
K915414 TERUMO ANGIOGTAPHIC CATHETER Terumo Medical Corp. DQO Class II 1992-02-04
K913994 MONARCH(TM) INFLATION SYRINGE Merit Medical Systems, Inc. MAV Class II 1992-02-04
K912835 MINI-PACK 911 SERIES Pace Tech, Inc. MHX Class II 1992-02-03
K920086 SHOCK-PATCH ADULT DEFIBRILLATION PADS Cardiotronics, Inc. LDD Class II 1992-02-03
K914595 PULSE RATE MONITOR Fitness Quest, Inc. DPZ Class II 1992-01-31
K915769 MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR Medtronic Vascular DXH Class II 1992-01-30
K914381 HORIZON 9000/HIS OPTION AMPLIFIER Mennen Medical, Inc. DRR Class II 1992-01-28
K913576 DATASCOPE MODEL VISA CENTRAL MONITOR Accucore, Inc. DSI Class II 1992-01-28
K915007 PERMANENT PACING LEADS, MODIFICATION Oscor Medical Corp. DTB Class III 1992-01-27
K915167 GESCO PER-Q-CATH CATHETER INTRODUCER Gesco Intl., Inc. DYB Class II 1992-01-27
K914976 OPTI-PLAST 5F PTA CATHETERS, MODIFICATION Vas-Cath, Inc. LIT Class II 1992-01-27
K915008 PERMANENT PACING PAD, MODIFICATION Oscor Medical Corp. DTB Class III 1992-01-27
K914185 PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. LDF Class II 1992-01-27
K913094 DISPOSABLE SLIDE VALVE MANIFOLD Professional Medical Services DQO Class II 1992-01-27
K915136 ATRAUMATIC TIP ANGIOGRAPHIC CATHETER Exonix Research Corp. DQO Class II 1992-01-27
K915879 HL-300 RECEIVER MODULE Fukuda Denshi USA, Inc. DPS Class II 1992-01-27
K915472 ELECTROCARDIOGRAPH TRANSMITTER Tz, Inc. DXH Class II 1992-01-24
K913374 CARDIO PERFECT, CARDIO PERFECT MD Cardio Control BV DPS Class II 1992-01-23
K911722 OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630 Cas Medical Systems, Inc. DXN Class II 1992-01-22
K913915 BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV Bard Cardiosurgery Div DTN Class II 1992-01-21
K911270 LEOCOR GUIDING CATHETER Leocor, Inc. DQO Class II 1992-01-17
K913956 BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 Bentley Laboratories, Inc. DTN Class II 1992-01-17
K915255 CDI(TM) 300, 400 & 100, MODIFICATION 3M Company DRY Class II 1992-01-15
K910994 MODIFIED SEISMOCARDIOGRAPH Seismed Instruments, Inc. DSB Class II 1992-01-15
K915265 CDI(TM) H/S CUVETTE, MODIFICATION 3M Company DRY Class II 1992-01-15
K913611 COWBOY Kinetic Concepts, Inc. JOW Class II 1992-01-13
K914523 CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL Catheter Research C/O Burditt, Bowles & Radzius DSS Class II 1992-01-10
K914838 PROPAQ 102,104,106,102EL,104EL,&106EL Protocol Systems, Inc. MHX Class II 1992-01-10
K912562 ABCOM 2000 Applied Biometrics, Inc. DPW Class II 1992-01-09
K914972 CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS Baxter Healthcare Corp KRH Class II 1992-01-09
K913077 LANCASTER COOLING JACKET, CAT. CODE #13500/13501 Dlp, Inc. DTR Class II 1992-01-09
K911615 HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 Diagnostic Monitoring Software DQK Class II 1992-01-08
K913339 HORIZON PACEMAKER DETECTION SOFTWARE Mennen Medical, Inc. DSI Class II 1992-01-08
K914828 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF Advanced Cardiovascular Systems, Inc. DQX Class II 1992-01-08
K915481 B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT Bd Becton Dickinson Vacutainer Systems Preanalytic DWD Class II 1992-01-07
K915480 B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. Bd Becton Dickinson Vacutainer Systems Preanalytic DWD Class II 1992-01-07
K915482 B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT Bd Becton Dickinson Vacutainer Systems Preanalytic DWD Class II 1992-01-07
K914805 TC-1000, TC-1050 SYSTEM Gaymar Industries, Inc. DWJ Class II 1992-01-07
K914581 HEART TECHNOLOGY WIRECLIP Heart Technology, Inc. DQX Class II 1992-01-06
K914555 WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) Med Institute, Inc. DRE Class II 1992-01-03
K913919 UNIVERSAL TERMINAL CAP, 3.2MM Telectronics Pacing Systems, Inc. KFJ Class III 1991-12-31
K914500 OPTI-PLAST 5F PTA CATHETERS, MODIFICATION Vas-Cath, Inc. LIT Class II 1991-12-31
K910665 MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED Ge Medical Systems Information Technologies DRT Class II 1991-12-31
K914576 KELLER CARDIAC MONITOR MEDIL KMS870 Keller Medical Specialties Products, Inc. DRT Class II 1991-12-30
K913521 XEMEX TEMPORARY PACING CATHETER A MODIFIED Zeon Medical Corp. LDF Class II 1991-12-27
K911702 OLYMPUS RETRACTABLE VALVULOTOME Olympus Corp. MGZ Class II 1991-12-27
K912409 MODEL HD-207 BIDIRECTIONAL VELOCITY METER Koven and Assoc., Inc. JOP Class II 1991-12-23
K913358 MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST Ppg Industries, Inc. DXG Class II 1991-12-20
K914985 DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION E-Z-Em, Inc. DRC Class II 1991-12-20
K914330 SOS BLOODLESS NEEDLE E-Z-Em, Inc. DYB Class II 1991-12-20
K905073 CARDIOVASCULAR REPAIR PATCH Impra, Inc. DXZ Class II 1991-12-20
K913363 CUSTOM TUBING PACKS Kroy Medical, Inc. DTL Class II 1991-12-20
K912588 AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS Sein Electronics Co., Ltd. DXN Class II 1991-12-19
K914974 MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST Medtronic Vascular DPS Class II 1991-12-19
K914863 CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT Cordis Corp. DQX Class II 1991-12-18
K914422 DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE Devices For Vascular Intervention, Inc. DQY Class II 1991-12-18
K911320 EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE Applied Biometrics, Inc. JOP Class II 1991-12-18
K913691 CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES Gish Biomedical, Inc. DTR Class II 1991-12-18
K914567 CORDIS BIPAL BIOPSY FORCEPS Cordis Corp. DWZ Class II 1991-12-18
K914199 ANGIOGRAPHIC SOFT TIP CATHETER E-Z-Em, Inc. DQO Class II 1991-12-18
K914208 MERIT DISPOSAL DEPOT(TM) Merit Medical Systems, Inc. DQO Class II 1991-12-18
K913484 ZOLL D-900 DEFIBRILLATOR Zmi Corp. LDD Class II 1991-12-16
K914149 FEMORAL ARTERY PRESSURE PAD/DISK Disco, Inc. DXC Class II 1991-12-13
K914138 ONTRAC Lake Region Mfg., Inc. DQX Class II 1991-12-13
K912446 MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 Vasamedics, LLC DPW Class II 1991-12-12
K912532 ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH Interventional Therapeutics Corp. DQO Class II 1991-12-11
K914067 RETRIEVAL DEVICE Target Therapeutics DQO Class II 1991-12-10

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