meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1991-12-09

Clearances · page 132 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K914458 ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION Medical Data Electronics LDD Class II 1991-12-09
K912744 ORG-8200A UNIVERSAL SIGNAL HOUSING Nihon Kohden America, Inc. DSI Class II 1991-12-09
K914009 SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER Schneider Intl., Ltd. DQO Class II 1991-12-06
K912293 REMOVE LABELING RESTRICT FROM GUIDE WIRES Target Therapeutics DQX Class II 1991-12-05
K914762 MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR Micromed DPS Class II 1991-12-05
K912049 SYSTEM ATHENA - PRODUCT ENHANCEMENTS S & W Medico Teknik DRT Class II 1991-12-05
K914971 TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION Nihon Kohden America, Inc. LDD Class II 1991-12-04
K914742 MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF Medtronic Vascular DTR Class II 1991-12-04
K903940 TYPE 9210 S/ECG S & W Medico Teknik DSI Class II 1991-12-04
K912082 SAFE II Polystan A/S DTZ Class II 1991-12-04
K912188 DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 Critikon Company, LLC MHX Class II 1991-12-04
K911883 DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER Diag Corp. DYB Class II 1991-11-29
K913875 BARD(R) BIOPOTENTIAL AMPLIFIER II Bard Electrophysiology DRQ Class II 1991-11-27
K914128 CONNECTING SET Procedure Products, Inc. DQO Class II 1991-11-27
K914116 PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION Medtronic Vascular DSY Class II 1991-11-27
K913027 VESSEL DILATOR Deseret Medical, Inc. DRE Class II 1991-11-27
K913871 FLOSWITCH(R) HP Boston Scientific Corp DQO Class II 1991-11-25
K914460 MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES Medtronic Vascular DRF Class II 1991-11-22
K914352 CORDIS OBTURATOR Cordis Corp. DYB Class II 1991-11-22
K913052 ITC GUIDING CATHETER Interventional Therapeutics Corp. DQY Class II 1991-11-22
K914602 DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED The Heart Valve Div. Medtronic Cardiovascular Surg KRH Class II 1991-11-22
K914312 SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS Scimed Life Systems, Inc. DQO Class II 1991-11-22
K913830 SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS Scimed Life Systems, Inc. DQY Class II 1991-11-22
K914001 TARGET THERAPEUTICS RADIOPAQUE STYLET Target Therapeutics DRB Class II 1991-11-22
K913827 MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG Hewlett-Packard Co. DPW Class II 1991-11-19
K912281 ES1600 PARAMEDIC TELEPHONE Epic Systems, Inc. DXH Class II 1991-11-19
K913805 MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER Pace Medical DTE Class II 1991-11-19
K913692 VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) Bentley Laboratories, Inc. DTN Class II 1991-11-15
K913682 MERIT CUSTOM KIT Merit Medical Systems, Inc. DQO Class II 1991-11-15
K912880 VITALMAX 510/520 Pace Tech, Inc. DQA Class II 1991-11-14
K913695 NELLCOR(R) N-180 PULSE OXIMETER Nellcor, Inc. DQA Class II 1991-11-13
K914046 THE BIG EASY Y-ADAPTER Microvena Corp. DYB Class II 1991-11-08
K914200 VASCUMAP MEDICAL AIR PLETHYSMOGRAPH Carolina Medical Electronics DSB Class II 1991-11-07
K911871 CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS Cardiodyne, Inc. DXN Class II 1991-11-07
K912404 TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY Hewlett-Packard Co. DPT Class II 1991-11-07
K913533 MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) Hewlett-Packard Co. DXH Class II 1991-11-07
K914100 STETHOSCOPE Atlas Medical Products, Inc. LDE Class I 1991-11-07
K913176 DELPHIN II CENTRIFUGAL SYSTEM 3M Health Care, Sarns KFM Class II 1991-11-07
K913523 AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR Omron Healthcare, Inc. DXN Class II 1991-11-06
K913391 TEGWIRE (TM) Boston Scientific Corp LIT Class II 1991-11-05
K914450 GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE W. L. Gore & Associates, Inc. DXZ Class II 1991-11-05
K913517 ISOLATE INFUSION CATHETR SYSTEM Lake Region Mfg., Inc. DQY Class II 1991-11-05
K912969 TORQUE FITTING Freedom Machine, Inc. DTL Class II 1991-11-05
K910997 DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON Datascope Corp. DSP Class II 1991-11-05
K910017 Q4500 STREE TEST MONITOR Quinton, Inc. DPS Class II 1991-11-05
K914725 COORDINATOR, CABLE INPUT Cardiotronics, Inc. DPS Class II 1991-11-05
K914447 GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE W. L. Gore & Associates, Inc. DSY Class II 1991-11-05
K914448 GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE W. L. Gore & Associates, Inc. DXZ Class II 1991-11-05
K912477 ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION Interventional Therapeutics Corp. DQO Class II 1991-11-05
K913074 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE Terumo Medical Corp. DQX Class II 1991-11-05
K913516 MODEL 520A NOVAMETRIX PULSE OXIMETER Novametrix Medical Systems, Inc. DQA Class II 1991-11-04
K912045 TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST Lifestream Int'L, Inc. DXS Class II 1991-10-31
K913451 HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS Hewlett-Packard Co. DSI Class II 1991-10-31
K914672 QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE Medicotest, Inc. DRX Class II 1991-10-31
K911761 SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION S & W Medico Teknik DQA Class II 1991-10-31
K913397 MEGA ANGIOGRAM KIT Mega Medical, Inc. DQO Class II 1991-10-31
K913489 SIEMENS MICRO2 PULSE OXIMETER Siemens Medical Electronics DQA Class II 1991-10-30
K911965 ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR Citizen Watch Co., Ltd. DXN Class II 1991-10-28
K912604 SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF Aries Medical, Inc. KFM Class II 1991-10-28
K913631 .014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1991-10-28
K914090 DAIG FAST CATH(TM) INTRODUCER, MODIFICATION Daig Corp. DYB Class II 1991-10-28
K913375 TORQUE TUBE STEEROCATH(TM) Ep Technologies, Inc. DRF Class II 1991-10-25
K913143 OCHSNER ULP BIFURCATION VASCULAR PROTHESIS Intervascular, Inc. DSY Class II 1991-10-23
K913353 VASCULAR GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1991-10-23
K913734 BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER Augustine Medical, Inc. DWJ Class II 1991-10-23
K911710 HEPARIN COATED THERMODILUTION CATH & ACCESSORIES Sunscope Intl., Inc. DQO Class II 1991-10-23
K912079 SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY 3M Health Care, Sarns DTZ Class II 1991-10-23
K913328 .010 HI-TORQUE PLUS(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1991-10-23
K912773 UNIPOLAR UPSIZING ADAPTOR Telectronics Pacing Systems, Inc. DTD Class II 1991-10-23
K913332 CIBA CORNING MODEL 270 CO-OXIMETER Ciba Corning Diagnostics Corp. DQA Class II 1991-10-23
K914141 CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER Cordis Corp. DQO Class II 1991-10-23
K913161 MERIT MANIFOLD Merit Medical Systems, Inc. DTL Class II 1991-10-21
K912636 ANNULUS VALVULOTOME Cardio Source MGZ Class II 1991-10-18
K913783 CORDIS PTCA GUIDING CATHETER, MODIFICATION Dow Corning Wright DQY Class II 1991-10-18
K914007 CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH Cordis Corp. DQO Class II 1991-10-18
K912635 ANNULUS DISPOSABLE VALVULOTOME Cardio Source MGZ Class II 1991-10-18
K912144 SIMON NITINOL FILTER, MODIFICATION Nitinol Medical Technologies, Inc. DTK Class II 1991-10-17
K913288 MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS Medtronic Vascular DTB Class III 1991-10-17
K911456 MODEL #110 STEALTH-TRODE CHILD DEFIB PADS Cardiotronics, Inc. LDD Class II 1991-10-16
K905403 MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER Cook Pacemaker Corp. DXY Class III 1991-10-16
K913689 SUB-4(TM), PERIPHERAL DILATATION CATHETER Boston Scientific Corp LIT Class II 1991-10-16
K910884 CARD GUARD, MODELS CG-6000 & CG-7000 Card Guard Scientific Survival , Ltd. DSH Class II 1991-10-16
K913193 MODEL 100 CENTRAL STATION Protocol Systems, Inc. DQK Class II 1991-10-16
K913801 CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL Cordis Corp. DYB Class II 1991-10-16
K911455 MODEL #100 SHOCK-TRODE CHILD DEFIB PADS Cardiotronics, Inc. LDD Class II 1991-10-16
K913600 WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM Ralin Laboratories, Inc. DSH Class II 1991-10-16
K911869 IVT GUIDING CATHETER Intensive Technology, Inc. DQY Class II 1991-10-16
K912621 MODEL #911 STEALTH MULTI PADS Cardiotronics, Inc. LDD Class II 1991-10-16
K911598 DATASCOPE PASSPORT MONITOR Datascope Corp. DRT Class II 1991-10-15
K910421 SATURATION/HEMATOCRIT MONITOR SYSTEM Medtronic Vascular DRY Class II 1991-10-15
K912107 GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM W. L. Gore & Associates, Inc. DXZ Class II 1991-10-11
K913263 VITALMAX 830 SERIES Pace Tech, Inc. MHX Class II 1991-10-10
K913110 PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED Microwave Medical Systems, Inc. DRQ Class II 1991-10-10
K911687 VER-MED A10020 RESTING EKG ELECTRODE Vermont Medical, Inc. DRX Class II 1991-10-10
K913297 SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH Schneider Intl., Ltd. LIT Class II 1991-10-10
K911472 BIO-SENSOR 01 EKG ELECTRODE Bio-Sensor, Inc. DRX Class II 1991-10-10
K911662 MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS Marquette Electronics, Inc. LDD Class II 1991-10-10
K912050 NOVOSTE VESSEL DILATER Novaste Corp. DRE Class II 1991-10-09
K904747 PEI PLAQUE ELECTRODE ARRAY Prucka Engineering, Inc. DRF Class II 1991-10-09
K912008 TRU-VIEW MULTI-CHANNEL DISPLAY General Devices DRT Class II 1991-10-09

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