meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
38
Latest Decision
1996-08-07

Clearances · page 116 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960422 PRUITT SAFETY OCCLUSION CATHETER Ideas For Medicine, Inc. MJN Class II 1996-08-07
K960430 CONTROL SYRINGE Scientific Device Manufacturer, LLC DXT Class II 1996-08-06
K960499 HEARTRAK XL Universal Medical, Inc. DXH Class II 1996-08-06
K961450 SCORE SOFTWARE Nellcor Puritan Bennett, Inc. DQA Class II 1996-08-01
K955534 SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) International Innovations, Inc. KRA Class II 1996-08-01
K961777 ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 Cardio Metrics, Inc. DQX Class II 1996-07-31
K960925 NORTHEAST MONITORING DR180 North East Monitoring, Inc. DSH Class II 1996-07-31
K961679 TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS Medtronic Vascular DTB Class III 1996-07-30
K955828 MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS Graphic Controls Corp. MKJ Class III 1996-07-25
K952979 HANC NETWORK Healthtech Services Corp. DXN Class II 1996-07-25
K962122 SENTRY RADIOTRANSLUCENT ECG ELECTRODES Sentry Medical Products, Inc. DRX Class II 1996-07-24
K955815 G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE Cmc Sense-It, Inc. DRX Class II 1996-07-23
K953762 HEART 400 ECG TRANSMITTER Aerotel, Ltd. DXH Class II 1996-07-18
K961717 NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS Naltiac Medical, Inc. DWF Class II 1996-07-18
K960721 PACEART WRIST ELECTRODES Paceart, Inc. DRX Class II 1996-07-18
K961763 PULSE*SPRAY INFUSION SYSTEM Angiodynamics, Div. E-Z-Em, Inc. QEY Class II 1996-07-17
K952969 EIDOS 5003 HOLTER SYSTEM New Product Development, Inc. DQK Class II 1996-07-16
K955416 CARDIMAX MODEL FX-2111 Fukuda Denshi USA, Inc. DPS Class II 1996-07-15
K951902 PATHFINDER 700 HOLTER ANALYZER Reynolds Medical , Ltd. DQK Class II 1996-07-15
K961118 MAXIM PF MODELS 033-581/033-590 Telectronics Pacing Systems, Inc. DTB Class III 1996-07-15
K954900 3M RED DOT ECG LEAD WIRES A Minnesota Mining and Mfg. Co. DSA Class II 1996-07-15
K954773 QUICKELS QS 100 SYSTEM Ferguson Medical DRX Class II 1996-07-11
K954163 RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER Cardiac Evaluation Center, Inc. DXH Class II 1996-07-11
K955045 OMNI-TRAK PATIENT MONITORING SYSTEM Invivo Research, Inc. DPS Class II 1996-07-11
K954772 QUICKELS QS 200 SYSTEM Ferguson Medical DRX Class II 1996-07-11
K961362 AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE Aerotel, Ltd. DXH Class II 1996-07-10
K961445 RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL Terumo Medical Corp. DQX Class II 1996-07-09
K955743 SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 1996-07-08
K961294 SCIMED DISPATCH GOLD CORONARY CATHETER Scimed Life Systems, Inc. KRA Class II 1996-07-03
K961857 LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 Graham-Field, Inc. DQD Class II 1996-07-03
K961358 ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER Arrow Intl., Inc. DSP Class II 1996-07-02
K960319 A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 1996-07-02
K960329 DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD Contour Medical Technology, Inc. MKJ Class III 1996-07-02
K960917 PERCUGLIDE Scientific Device Manufacturer, LLC DRE Class II 1996-07-02
K955642 NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER Nellcor Puritan Bennett, Inc. DPS Class II 1996-07-02
K960200 INTROSTAT LEAD INTRODUCER Msi, Inc. DYB Class II 1996-07-02
K942227 NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM C.L. Mcintosh & Assoc., Inc. DSB Class II 1996-06-28
K961404 MX960 REUSABLE PRESSURE TRANSDUCER Medex, Inc. DRS Class II 1996-06-27
K961271 USCI COMMANDER SERIES GUIDE WIRES C.R. Bard, Inc. DQX Class II 1996-06-27
K961232 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP Biocompatibles , Ltd. DQX Class II 1996-06-26
K961461 DANESHVAR'S DEVICE (MODIFICATION) Y. Daneshvar DXC Class II 1996-06-26
K955853 HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM Healthcare Service and Supply JOW Class II 1996-06-25
K943657 STERILIZATION Telectronics Pacing Systems, Inc. DTB Class III 1996-06-24
K961180 NMI ANTEGRAD CARDIOPLEGIA CANNULA Naltiac Medical, Inc. DWF Class II 1996-06-21
K961181 NMI VEIN GRAFT PERFUSION SET Naltiac Medical, Inc. DTL Class II 1996-06-21
K953649 DISPOSABLE ECG ELECTRODE Kendall-Ltp DRX Class II 1996-06-21
K955550 CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1996-06-19
K961134 BARD GRAFT SIZER C.R. Bard, Inc. DSY Class II 1996-06-19
K961100 MICRO ANASTOMOSIS CLAMP R.S.P. Medical Management, Inc. DXC Class II 1996-06-19
K961245 HEARTPORT ENDOPULMONARY VENT Heartport, Inc. DWF Class II 1996-06-18
K950944 AMBULATORY (HOLTER) RECORDING SYSTEM Biosensor Corp. DQK Class II 1996-06-18
K960281 IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY Intermedics, Inc. DTB Class III 1996-06-18
K961270 HEARTPORT ENDOSINUS CATHETER Heartport, Inc. DWF Class II 1996-06-18
K961009 STRESSWRITER EXERCISE TESTING SYSTEM Hewlett-Packard Co. DQK Class II 1996-06-17
K960167 SYSTEM, THERMAL REGULATING 74-DWJ Augustine Medical, Inc. DWJ Class II 1996-06-17
K955342 OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER Rashman Corp. DXN Class II 1996-06-17
K960934 HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 Hewlett-Packard Co. MLD Class II 1996-06-14
K961301 E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 Delphi Consulting Group DQD Class II 1996-06-11
K961395 MEDI-TRACE RADIOLUCENT Graphic Controls Corp. DRX Class II 1996-06-07
K955059 OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER Siemens Medical Solutions USA, Inc. DSI Class II 1996-06-07
K955132 HEARTPORT ENDOAORTIC CLAMP Heartport, Inc. DXC Class II 1996-06-07
K952054 SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960) Siemens Medical Solutions USA, Inc. DSI Class II 1996-06-07
K961527 MX703 AND MX730 CONTINUOUS FLUSH DEVICES Medex, Inc. KRA Class II 1996-06-06
K960676 ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 Zoll Medical Corp DTE Class II 1996-06-05
K960614 SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) Somanetics Corp. DQA Class II 1996-06-05
K960937 SUCTION SAFETY DEVICE R D Intl. MJJ Class II 1996-06-05
K960916 SAMS 8000 CARDIOPLEGIA MONITOR 3M Health Care, Sarns DSJ Class II 1996-06-04
K961063 AS/3 CARDIAC OUTPUT & SVO2 MODULE Datex Medical Instrumentation, Inc. DQK Class II 1996-05-31
K960449 PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) Biosensor Corp. DPS Class II 1996-05-30
K960983 MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT Medtronics Interventional Vascular MAV Class II 1996-05-30
K955460 MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1996-05-30
K954852 SOLAR 9000 ANESTHESIA INFORMATION MONITOR Marquette Electronics, Inc. DSI Class II 1996-05-29
K960832 OCCLUSION BALLOON CATHETER Interventional Therapeutics Corp. MJN Class II 1996-05-29
K960532 PRECLUDE IMA SLEEVE W. L. Gore & Associates, Inc. MFX Class II 1996-05-23
K960755 CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS Medtronic Cardiac Surgery, Medtronic, Inc. DQX Class II 1996-05-23
K960446 MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES Medtronic Vascular DSA Class II 1996-05-22
K952417 QUEST EXERCISE STRESS SYSTEM Burdick, Inc. DSI Class II 1996-05-22
K960718 LRM Lake Region Mfg., Inc. DQX Class II 1996-05-21
K944497 UNILECT, MONITAB AND BIOTRACE-HR Msb , Ltd. DRX Class II 1996-05-17
K955800 SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE Cmc Sense-It, Inc. DRX Class II 1996-05-17
K944496 BIOTRACE-N, NS, 410 AND RT Msb , Ltd. DRX Class II 1996-05-16
K954389 CONMED ECG/EKG ELECTRODES Conmedcorp DRX Class II 1996-05-16
K955304 CRICKET Microvena Corp. DQX Class II 1996-05-16
K960058 OXITEMP, 3301T SA Bci Intl., Inc. DQA Class II 1996-05-15
K955689 RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY Contour Fabricators of Florida, Inc. DWS Class I 1996-05-15
K960713 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) Arrow Intl., Inc. DSP Class II 1996-05-15
K961015 SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1996-05-15
K954457 MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER Medi-Tech, Inc. KRA Class II 1996-05-15
K961280 SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F Scimed Life Systems, Inc. DQY Class II 1996-05-15
K955533 DIASTAT VASCULAR ACCESS GRAFT W. L. Gore & Associates, Inc. DYF Class II 1996-05-15
K955380 IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) International Biophysics Corp. DRY Class II 1996-05-14
K955379 IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) International Biophysics Corp. DRY Class II 1996-05-14
K961513 PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET Ep Medsystems DYB Class II 1996-05-13
K950989 CARDIOSMART Hellige GmbH DPS Class II 1996-05-13
K955121 HEARTPORT ENDOARTERIAL RETURN CANNUAL Heartport, Inc. DWF Class II 1996-05-10
K950967 M.I.C. V.V.T. Healthcare Technologies, Inc. JOW Class II 1996-05-08
K961471 INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) Advanced Cardiovascular Systems, Inc. MAV Class II 1996-05-08
K954957 CODEMASTER XL + XL W/SHOCK ADVISORY OPTION Hewlett-Packard Co. MKJ Class III 1996-05-07
K954267 BURDICK 200 PULSE OXIMETER Burdick, Inc. DQA Class II 1996-05-03
K955684 RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY Contour Fabricators of Florida, Inc. DXT Class II 1996-05-02

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