meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1997-05-15

Clearances · page 113 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971148 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES Cardiotronics Systems, Inc. MKJ Class III 1997-05-15
K964832 HEWLETT-PACKARD CENTRALVUE SOFTWARE Hewlett-Packard Co. DSI Class II 1997-05-15
K963904 P.H.D. - PERSONAL HEART DEVICE MODEL 5258 Heart Alert, Inc. DXH Class II 1997-05-15
K970784 ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) Alexander Mfg. Co. DXG Class II 1997-05-14
K970787 ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) Alexander Mfg. Co. DPS Class II 1997-05-14
K964518 FAST-CATH TRANSSEPTAL CATHETER INTRODUCER Daig Corp. DYB Class II 1997-05-14
K970914 CHASE AORTIC PERFUSION CANNULA Chase Medical, Inc. DWF Class II 1997-05-13
K971041 CHASE CORONARY OSTIAL PERFUSION CANNULA Chase Medical, Inc. DWF Class II 1997-05-13
K964391 CHASE LEFT VENT SAFETY VALVE Chase Medical, Inc. DWF Class II 1997-05-13
K964302 HEARTPORT THORACIC TROCAR Heartport, Inc. DRC Class II 1997-05-09
K970494 HANNIBAL GUIDEWIRE Schneider (Europe) GmbH DQX Class II 1997-05-09
K970725 OPTI-PLAST XL 5.5 F PTA CATHETER Vas-Cath, Inc. LIT Class II 1997-05-09
K970545 DASH 1000 PATIENT MONITOR Marquette Medical Systems, Inc. DSI Class II 1997-05-08
K970469 EVT ANGIOSCALE ANGIOGRAPHIC CATHETER Guidant Cardiac and Vascular Surgery DQO Class II 1997-05-08
K963962 VISTA BRITE TIP CATHETERS Cordis Corp. DQY Class II 1997-05-07
K964814 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. DYB Class II 1997-05-07
K955816 VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR Baxter Healthcare Corp DYG Class II 1997-05-06
K964033 3F ANGIOPTIC ANGIOGRAPHIC CATHETER AngioDynamics, Inc. DQO Class II 1997-05-06
K964188 HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT Healthcare Service and Supply JOW Class II 1997-05-06
K970368 SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER Siemens Medical Solutions USA, Inc. DQA Class II 1997-05-06
K964034 TRANSJUGULAR ACCESS SET AngioDynamics, Inc. DYB Class II 1997-05-06
K970463 CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR Terumo Medical Corp. DTZ Class II 1997-05-06
K970620 CORDIS OPTA5 PTA BALLOON CATHETER Cordis Corp. LIT Class II 1997-05-06
K970902 MEDILOG FD4 Oxford Instruments Medical Systems DSH Class II 1997-05-05
K964625 HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES Intervascular, Inc. DSY Class II 1997-05-05
K963418 TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE Transmedica, Inc. DQD Class II 1997-05-02
K970379 CHANNEL BALLOON CATHETER Boston Scientific Corp LIT Class II 1997-05-01
K964187 FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR Fukuda Denshi USA, Inc. DSI Class II 1997-05-01
K964642 MEDRAD DISPOSABLE SYRINGES Medrad, Inc. DXT Class II 1997-04-29
K970204 BK-A; BK-B; BK-IS SEALING CAP Biotronik, Inc. DTD Class II 1997-04-29
K962930 SPACELABS MEDICAL ECG ANALYSIS SYSTEM Spacelabs Medical, Inc. DQK Class II 1997-04-25
K970299 JUPITER PTA CATHETERS (VARIOUS) Cordis Corp. LIT Class II 1997-04-24
K963886 EVS Applied Medical Resources DYB Class II 1997-04-24
K970392 CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. DRE Class II 1997-04-24
K965183 VANTAGE PERIPHERAL DILATATION CATHETER Guidant Corp. LIT Class II 1997-04-24
K964393 CHASE RETROGRADE CARDIOPLEGIA CANNULA Chase Medical, Inc. DWF Class II 1997-04-23
K964377 THERMAL REGULATION SYSTEM BLANKET Gibeck, Inc. DWJ Class II 1997-04-23
K963731 TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT Enthermics Medical Systems, Inc. DWJ Class II 1997-04-22
K970201 GSI CANNULA WITH INTRODUCER General Surgical Innovations DYB Class II 1997-04-21
K964200 CHASE MULTIPLE PERFUSION SET Chase Medical, Inc. DWF Class II 1997-04-16
K964193 CHASE AORTIC ARCH CANNULA Chase Medical, Inc. DWF Class II 1997-04-16
K970099 SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM Nitinol Medical Technologies, Inc. DTK Class II 1997-04-16
K964194 CHASE CURVED LEFT HEART VENT CATHETER Chase Medical, Inc. DWF Class II 1997-04-16
K970719 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES Cardiotronics Systems, Inc. MKJ Class III 1997-04-16
K962129 CONTINUOUS FLUSH DEVICE Merit Medical Systems, Inc. KRA Class II 1997-04-15
K971192 IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT Impra, Inc. DSY Class II 1997-04-15
K970755 STEALTHSHIELD Vital Connections, Inc. DRX Class II 1997-04-15
K961924 IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM Irvine Biomedical, Inc. DRF Class II 1997-04-11
K962937 CARDIO TEAM II Vision Electronics DXH Class II 1997-04-10
K962700 VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT Vasamedics, LLC DPT Class II 1997-04-09
K970796 3M RED DOT 2560 & 2570 MONITORING ELECTRODES 3M Healthcare DRX Class II 1997-04-09
K964161 HEARTPORT ENDOAORTIC CLAMP Heartport, Inc. DXC Class II 1997-04-04
K945586 FLEXIBLE DILATING SHEATH Med Institute, Inc. DRE Class II 1997-04-04
K963503 CTS MIDCAB CORONARY SHUNT Cardiothoracic Systems, Inc. DXC Class II 1997-04-03
K952912 SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE Spacelabs Medical, Inc. DSI Class II 1997-04-02
K963716 MICS DEVICE SYSTEM Percutaneous Technologies, Inc. DXC Class II 1997-04-02
K964107 OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR Oscor Medical Corp. DTB Class III 1997-04-01
K954547 CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER Citizen Watch Co., Ltd. DXN Class II 1997-04-01
K970603 D SERIES ELECTRODE Cmc Sense-It, Inc. DSB Class II 1997-04-01
K961676 AIRCAST VENAFLOW SYSTEM (MODIFICATION) Aircast, Inc. JOW Class II 1997-03-28
K963688 FOCUS PV BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. LIT Class II 1997-03-28
K970244 SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES Scimed Life Systems, Inc. DQX Class II 1997-03-28
K970762 DUAL LUMEN EMBOLECTOMY CATHETER Applied Medical Resources DXE Class II 1997-03-28
K965214 COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) Coeur Laboratories, Inc. DTX Class II 1997-03-28
K960849 MAGNO ALARM Cardiac Assist Devices, Inc. DTG Class I 1997-03-26
K962970 SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION Spacelabs Medical, Inc. DSI Class II 1997-03-25
K965189 SPINNAKER Target Therapeutics KRA Class II 1997-03-24
K965181 CES INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 1997-03-21
K963057 FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER Fukuda Denshi USA, Inc. DSI Class II 1997-03-21
K964877 IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT Impra, Inc. DYF Class II 1997-03-20
K963698 CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 International Biophysics Corp. DTY Class II 1997-03-20
K960766 MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. DYF Class II 1997-03-19
K964198 CAHSE AORTIC ROOT CANNULA Chase Medical, Inc. DWF Class II 1997-03-19
K962141 VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 B.Braun Medical, Inc. DXT Class II 1997-03-19
K964195 CHASE TWO STAGE VENOUS RETURN CATHETER Chase Medical, Inc. DWF Class II 1997-03-19
K964199 CHASE CORONARY SINUS PERFUSION CANNULA Chase Medical, Inc. DWF Class II 1997-03-19
K962433 MEADOX EXXCEL EPTFE VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1997-03-17
K964987 DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 Datascope Corp. DSP Class II 1997-03-17
K965101 CARDIOBEEPER CB-12L Meridian Medical Technologies, Inc. DXH Class II 1997-03-17
K963174 HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) Del Mar Avionics DSH Class II 1997-03-13
K965051 HEARTPORT NEEDLE TROCAR Heartport, Inc. DRC Class II 1997-03-12
K961144 MS-2000 Touritu Engineering Co., Inc. DXN Class II 1997-03-12
K965211 VISTA BRITE TIP CATHETERS Cordis Corp. DQY Class II 1997-03-11
K963787 EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM Conmedcorp DRX Class II 1997-03-11
K963388 VESSEL DILATOR Maxxim Medical DRE Class II 1997-03-11
K964959 VASCUTEK TWILLWEAVE VASCULAR GRAFT Vascutek, Ltd. DSY Class II 1997-03-10
K964973 GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR Gish Biomedical, Inc. DTN Class II 1997-03-10
K964604 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION Biotronik, Inc. DTB Class III 1997-03-10
K944180 MODEL 700 Memtec Corp. DSH Class II 1997-03-07
K970391 QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES Contour Medical Technology, Inc. MKJ Class III 1997-03-06
K964967 BIOCOR 200 HIGH PERFORMANCEOXYGENATOR Minntech Corp. DTZ Class II 1997-03-06
K962547 CARDIOSERV P Marquette Electronics, Inc. DRO Class II 1997-03-06
K963198 PS-41 6M PATIENT SIMULATOR Metron U.S., Inc. DPS Class II 1997-03-05
K961661 OXIMETRIX 4 COMPUTER SYSTEM Abbott Laboratories DXG Class II 1997-03-04
K970125 NOAH MONITORING ELECTRODE SYSTEM Contour Medical Technology, Inc. DRX Class II 1997-03-04
K965023 CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1997-03-04
K963375 CARDIACMONITOR Vision Electronics DXH Class II 1997-02-28
K964888 HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II Tz Medical, Inc. DXH Class II 1997-02-28
K963120 RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM Marquette Electronics, Inc. DRO Class II 1997-02-28
K963576 MOBILE MEDICAL MONITOR (M3(A)) Scientific Applications DRT Class II 1997-02-28

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