meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
1997-08-14

Clearances · page 112 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K970388 A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE Biotronik, Inc. DTD Class II 1997-08-14
K971026 THE CIRCULATOR BOOT Circulator Boot Corp. DRN Class II 1997-08-14
K971930 BK-N SEALING CAP Biotronik, Inc. DTD Class II 1997-08-14
K963336 HARMAC THERMODILUTION CATHETER Harmac Medical Products, Inc. DYG Class II 1997-08-14
K964784 SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) Quinton, Inc. DPS Class II 1997-08-13
K942685 ECG REVIEW STATION Mortara Instrument, Inc. DXJ Class II 1997-08-12
K971021 CHASE PHRENIC NERVE PAD Chase Medical, Inc. DWF Class II 1997-08-12
K971827 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 Alexander Mfg. Co. DQA Class II 1997-08-12
K971828 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 Alexander Mfg. Co. DQA Class II 1997-08-12
K965066 ARRHYTHMIA MAPPING SYSTEM (8100/8300) Cardiac Pathways Corp. DRF Class II 1997-08-11
K963925 THROMBOLYTIC BRUSH CATHETER Micro Therapeutics, Inc. MCW Class II 1997-08-08
K964571 VISION CARDIOPLEGIA DELIVERY SYSTEM Lifestream Int'L, Inc. DTR Class II 1997-08-08
K970027 FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 Rmds, Inc. DXC Class II 1997-08-08
K970014 TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) Delphi Consulting Group JOW Class II 1997-08-06
K971673 40 CC SUMO Boston Scientific Corp DSP Class II 1997-08-05
K964017 AFFINITY BLOOD PUMP SYSTEM Avecor Cardiovascular, Inc. DTQ Class II 1997-08-05
K970401 MEDI-DYNE GUIDING CATHETER Medi-Dyne, Inc. DQY Class II 1997-08-01
K970207 MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS Boston Scientific Corp DQO Class II 1997-07-31
K970470 EVT EXPANDABLE SHEATH Guidant Cardiac and Vascular Surgery DRE Class II 1997-07-31
K970920 SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 1997-07-29
K964425 A-V IMPULSE SYSTEM MODEL 6060 Powell,Goldstein,Frazer & Murphy JOW Class II 1997-07-28
K971604 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP Alexander Mfg. Co. DSH Class II 1997-07-28
K964836 CARD GUARD, MODEL CG-7100 Card Guard Scientific Survival , Ltd. DXH Class II 1997-07-28
K955890 FIRST MEDIC PULSE OXIMETRY MODULE Colorado Medtech, Inc. MKJ Class III 1997-07-28
K970080 ARROW-TREROTOLA PTD CATHETER Arrow Intl., Inc. MCW Class II 1997-07-25
K970375 ANNULOFLO SYSTEM Carbomedics, Inc. KRH Class II 1997-07-25
K965167 PERCUTANEOUS VENOUS INTRODUCER 10264 Medamicus, Inc. DYB Class II 1997-07-25
K971607 MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS Boston Scientific Corp DQO Class II 1997-07-24
K964408 POSEIDON CARDIAC MONITORING SYSTEM (PCMS) Instromedix, Inc. DPS Class II 1997-07-23
K965247 ENVOY GUIDING CATHETER Cordis Neurovascular, Inc. DQY Class II 1997-07-23
K963987 CAMOUFLAGE CUFF SAVERS N.A. Braggs Medical, Inc. DXQ Class II 1997-07-23
K971669 COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. DTN Class II 1997-07-23
K971516 CORDIS POWERFLEX PLUS PTA BALLOON CATHETER Cordis Corp. LIT Class II 1997-07-23
K971968 SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) Remington Medical, Inc. DSA Class II 1997-07-23
K971165 INTRODUCER SHEATH AND DILATOR Boston Scientific Corp LDF Class II 1997-07-23
K963898 MODEL 6495 BIPOLAR TEMPORARY PACING LEAD Medtronic Vascular LDF Class II 1997-07-22
K971019 CHASE VESSEL CANNULA Chase Medical, Inc. DWF Class II 1997-07-21
K963790 UNI-GRAFT K DV Atrium Medical Corp. DSY Class II 1997-07-21
K971608 CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. DYB Class II 1997-07-21
K964036 CARDIOMAGIC 2000 SOFTWARE Instromedix, Inc. DXH Class II 1997-07-18
K971579 CORDIS OPTA 5 PTA BALLOON CATHETER Cordis Corp. LIT Class II 1997-07-18
K964821 COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 Ventrex, Inc. DQA Class II 1997-07-16
K965172 OXIMETER PRE-AMP CABLE Epic Medical Equipment Services, Inc. DQA Class II 1997-07-16
K971355 NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES Nihon Kohden America, Inc. LDD Class II 1997-07-15
K971646 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER Cordis Corp. DQO Class II 1997-07-14
K971306 FG INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 1997-07-14
K970763 MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR Medical Data Electronics DQA Class II 1997-07-14
K971572 VISTA BRITE TIP CATHETERS Cordis Corp. DQY Class II 1997-07-14
K971395 GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE Target Therapeutics DQX Class II 1997-07-14
K960974 COBE CENTURY PERFUSION PUMP Cobe Cardiovascular, Inc. DWB Class II 1997-07-14
K971474 MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL Medtronic Vascular DTE Class II 1997-07-14
K971105 MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM Avecor Cardiovascular, Inc. DTN Class II 1997-07-11
K964190 ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER Biotronik, Inc. DTE Class II 1997-07-10
K971815 ASC BALANCE MIDDLEWEIGHT GUIDE WIRE Guidant Corp. DQX Class II 1997-07-09
K971194 NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES Nihon Kohden America, Inc. LDD Class II 1997-07-09
K972001 NICAS(TM) ELECTRODE Ni Medical DRX Class II 1997-07-08
K961734 CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE Terumo Medical Corp. DTZ Class II 1997-07-07
K971448 CORDIS OPTA LP PTA BALLOON CATHETER Cordis Corp. LIT Class II 1997-07-03
K963190 QA-40M DEFIBRILLATOR TESTER Metron U.S., Inc. DRL Class II 1997-07-01
K971254 TRANSEND EX PLATINUM GUIDEWIRE Boston Scientific Corp DQX Class II 1997-07-01
K970481 V2 Survivalink Corp. LDD Class II 1997-07-01
K965236 SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) Datascope Corp. DSP Class II 1997-07-01
K970657 LMI THROMBECTOMY CATHETER Lucas Medical, Inc. DXE Class II 1997-07-01
K963578 PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) Intl. Products, Inc. DPS Class II 1997-06-30
K964593 DIASCOPE TRAVELLER PLUS (4053) S & W Medico Teknik A/S DSI Class II 1997-06-30
K971753 DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 Denver Biomaterials, Inc. DWM Class II 1997-06-27
K964673 BAIR HUGGER MODEL 630 CARDIAC BLANKET Augustine Medical, Inc. DWJ Class II 1997-06-26
K970012 ESCORT LINK CENTRAL STATION MONITOR Medical Data Electronics DSI Class II 1997-06-26
K963074 HARMAC QUADPOLAR MAPPING PACING CATHETER Harmac Medical Products, Inc. DRF Class II 1997-06-25
K962811 SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION Spacelabs Medical, Inc. DXJ Class II 1997-06-24
K971149 SVL-9130 DEFIBRILLATION ELECTRODE Survivalink Corp. MKJ Class III 1997-06-23
K964373 SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT 3M Healthcare DWF Class II 1997-06-18
K971577 FOCUS-PV BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. LIT Class II 1997-06-18
K964374 SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT 3M Healthcare DWF Class II 1997-06-18
K971010 PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS Cordis Corp. LIT Class II 1997-06-18
K971291 HEARTPORT ENDOARTERIAL RETURN CANNULA Heartport, Inc. DWF Class II 1997-06-17
K963920 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, Arrow Intl., Inc. DSP Class II 1997-06-17
K963575 HBF-1000 OMRON BODY COMPOSITION ANALYZER Omron Healthcare, Inc. MNW Class II 1997-06-13
K971444 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES 3M Medical Products Group DRX Class II 1997-06-11
K970528 CLYDE CORONARY GUIDEWIRE Schneider (Europe) GmbH DQX Class II 1997-06-10
K952172 HOTMAN Hemo Sapiens, Inc. DSB Class II 1997-06-10
K970376 PTCA GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 1997-06-06
K971235 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W Alexander Mfg. Co. DQA Class II 1997-06-05
K970843 INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular, Inc. DSY Class II 1997-06-05
K965137 FOGARTY VALVULOTOME MODEL 700091 Baxter Edwards MGZ Class II 1997-06-04
K965062 SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES Siemens Medical Solutions USA, Inc. DSI Class II 1997-06-04
K970497 PACE 101H Sulzer Oscor, Inc. DTE Class II 1997-06-04
K970823 SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. DQY Class II 1997-06-03
K971034 USCI MAINSTAY GUIDING CATHETER C.R. Bard, Inc. DQO Class II 1997-05-28
K970842 Cordis Endeavor Infusion Catheter Cordis Corp. QEY Class II 1997-05-28
K964881 ULTRAVERSE PTA CATHETER Vas-Cath, Inc. LIT Class II 1997-05-28
K963738 STELA MODEL BJ44 AND BJ45 PACING LEADS Ela Medical, Inc. DTB Class III 1997-05-23
K964251 OCCLUSION CLAMP** DEVICE United States Surgical, A Division of Tyco Healthc DXC Class II 1997-05-23
K964551 CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID Scimed Life Systems, Inc. DQX Class II 1997-05-21
K964978 VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) Quinton, Inc. DQA Class II 1997-05-21
K964868 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER Micro Therapeutics, Inc. KRA Class II 1997-05-20
K970690 LOCKING STYLET 2 Cook Pacemaker Corp. DQX Class II 1997-05-20
K970466 RADIUS PTCA GUIDEWIRE Radius Medical Technologies, Inc. LIT Class II 1997-05-20
K963781 ZOLL AUTOCLAVABLE INTERNAL HANDLES Zoll Medical Corp LDD Class II 1997-05-20
K953647 MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1997-05-16

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