meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
1999-03-02

Clearances · page 107 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K984322 DIDECO D920, LILLIPUT 1 TWIN RESERVOIR Dideco S.P.A. DTP Class II 1999-03-02
K964235 ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL Industrielle Entwicklung Medizintechnik Und Vertri DXN Class II 1999-03-02
K990106 ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES Bio-Detek, Inc. MKJ Class III 1999-02-26
K983534 7F HYDROLYSER THROMBECTOMY CATHETER Cordis Corp. QEZ Class II 1999-02-26
K982363 OASIS THROMBECTOMY CATHETER SYSTEM Boston Scientific Corp MCW Class II 1999-02-23
K983471 FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER Radi Medical Systems AB DXC Class II 1999-02-23
K984150 PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER Ep Medsystems DRF Class II 1999-02-22
K990380 (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700 Meditec Co., Ltd. DXN Class II 1999-02-22
K984294 MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular, Inc. DSY Class II 1999-02-22
K983314 PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM Nycomed Amersham Imaging IZQ Class II 1999-02-19
K982034 E-FAX SYSTEM Blakbag, Ltd., Division of Coherent Systems DXH Class II 1999-02-19
K983650 BIPORE BALLOON DILATATION CATHETER Bipore, Inc. LIT Class II 1999-02-17
K984089 ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW Zymed Medical Instrumentation DSI Class II 1999-02-16
K980723 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) Vascutech, Inc. MGZ Class II 1999-02-12
K984058 ACIST INJECTOR SYSTEM, MODEL CL100 H Acist Medical Systems IZQ Class II 1999-02-11
K984258 NEUROVASX SUB-MICROINFUSION CATHETER Neuro Vasx, Inc. DQO Class II 1999-02-11
K990027 OMNICORDER, MODEL 464 Del Mar Avionics DSH Class II 1999-02-09
K981720 IQ SYSTEM Renaissance Technology, Inc. DSB Class II 1999-02-08
K983372 BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP Sunscope Intl., Inc. DRS Class II 1999-02-05
K983626 KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II Alaris Medical Systems, Inc. DXH Class II 1999-02-05
K983506 PRESSUREWIRE SENSOR, MODEL #12001 Radi Medical Systems AB DQX Class II 1999-02-03
K984263 EWC: ECG II CABLE LEADWIRE SYSTEM Ewc DSA Class II 1999-02-02
K980631 EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA Embol-X, Inc. DXC Class II 1999-02-02
K984182 PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 Possis Medical, Inc. DSY Class II 1999-02-01
K984183 PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 Possis Medical, Inc. DYF Class II 1999-02-01
K982385 POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER Porous Media Corp. KRJ Class II 1999-02-01
K982559 GUIDEWIRE Galt Medical Corp. DQX Class II 1999-02-01
K983900 VENOMETER Advanced Medical Technology , Ltd. JOM Class II 1999-01-29
K990125 HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K Hewlett-Packard GmbH DSI Class II 1999-01-29
K981359 GT LEGGIERO Terumo Medical Corp. DQY Class II 1999-01-27
K982384 MERCATOR Harley Street Software , Ltd. DSH Class II 1999-01-27
K972065 AURORA Neurovena Corp. DQY Class II 1999-01-27
K982540 MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, Cardiac Pathways Corp. MTD Class II 1999-01-27
K984260 PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) Terumo Medical Corp. DYB Class II 1999-01-26
K982090 PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM Paceart, Inc. DXH Class II 1999-01-26
K982264 FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 Survivalink Corp. MKJ Class III 1999-01-25
K983796 6004 NIBP MONITOR WITH TEMPERATURE Bci Intl., Inc. DXN Class II 1999-01-22
K983744 MCAS (MODULAR CLIP APPLIER SYSTEM) Applied Medical Resources DSS Class II 1999-01-21
K983689 BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES Medicotest A/S DRX Class II 1999-01-15
K982228 FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 Tz Medical, Inc. DXH Class II 1999-01-14
K982419 HEART-LIFT BALLOON POSITIONER Cardiothoracic Systems, Inc. MWS Class I 1999-01-13
K984456 COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. DTN Class II 1999-01-11
K982272 GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 Biotronik, Inc. DQX Class II 1999-01-08
K962918 LIDCO SYSTEM Lidco, Ltd. DXG Class II 1999-01-08
K984435 MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M Medtronic Vascular KRH Class II 1999-01-07
K981376 HEWLETT-PACKARD M1205A VIRIDIA 24 CT Hewlett-Packard Co. DSI Class II 1999-01-04
K983055 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 Guidant Corp. LIT Class II 1998-12-30
K984500 CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. DYB Class II 1998-12-23
K982091 CS/3 COMPACT AIRWAY MODULE, M-COVX Datex-Engstrom, Inc. MHX Class II 1998-12-22
K983653 RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D Cardiac Pathways Corp. DRF Class II 1998-12-22
K984286 HEARTSTREAM ELECTRODE ADAPTER Hewlett-Packard Co. MKJ Class III 1998-12-17
K983769 DISTAFLO BYPASS GRAFT Impra, Inc. DYF Class II 1998-12-15
K981643 RTM DVT PROSOFT CUFF MODEL NUMBER PS100 R.T. Medical Services, Inc. JOW Class II 1998-12-14
K980845 MS-900S, MS-900SPM & MS-900SFM Mars Medical Products DXN Class II 1998-12-14
K982543 SILVERSTREAK HYDROPHILIC GUIDEWIRE Micro Therapeutics, Inc. DQX Class II 1998-12-11
K980973 MEDTRONIC ANGIOGRAPHIC CATHETER Medtronics Interventional Vascular DQO Class II 1998-12-10
K981737 K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 Katecho, Inc. MKJ Class III 1998-12-09
K982728 NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C Nellcor Puritan Bennett, Inc. DQA Class II 1998-12-07
K972991 MONITOR ONE NDX Qmed, Inc. DPS Class II 1998-12-03
K983026 PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 Card Guard Scientific Survival , Ltd. DXH Class II 1998-12-02
K974617 PERIPHERAL VASCULAR DILATOR Endovascular Instruments, Inc. DRE Class II 1998-12-01
K974259 VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE Edwards Lifesciences Research Medical DWF Class II 1998-12-01
K982797 BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB Luther Medical Products, Inc. DYB Class II 1998-11-30
K982104 ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 Medical Data Electronics MLD Class II 1998-11-25
K981802 ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 Bio-Detek, Inc. MKJ Class III 1998-11-25
K981909 BAXTER HEMOSTASIS VALVE INTRODUCERS Baxter Edwards DYB Class II 1998-11-24
K982986 TUBING BLOOD FLOW METER MODEL NUMBER HD-800 Koven Technology, Inc. DPW Class II 1998-11-24
K983861 DISTAFLO BYPASS GRAFT Impra, Inc. DSY Class II 1998-11-24
K983819 INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN Intervascular, Inc. DSY Class II 1998-11-24
K980278 URESIL VASCU-FLO INFUSION CATHETER Uresil Corp. DQY Class II 1998-11-20
K983307 MODIFICATION TO PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. MKJ Class III 1998-11-20
K983064 IMPRA HIGH POROSITY GRAFT Impra, Inc. DSY Class II 1998-11-19
K982657 AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 Microvena Corp. MCW Class II 1998-11-18
K983855 FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F Jawon Medical Co., Ltd. DXN Class II 1998-11-17
K980045 CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM Invivo Research, Inc. DSI Class II 1998-11-16
K983980 SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS Siemens Medical Solutions USA, Inc. DSI Class II 1998-11-16
K983582 CARDIOBEEPER CB250 Merdian Medical Technologies , Ltd. DXH Class II 1998-11-13
K982803 HEARTLINK, MODEL II Cardiac Telecom Corp. QYX Class II 1998-11-13
K981964 MEDI-TRACE 4103 NEONATAL ELECTRODE Graphic Controls Corp. DRX Class II 1998-11-13
K974241 SCIMED INFORMER PRESSURE WIRE SYSTEM Scimed Life Systems, Inc. DQX Class II 1998-11-12
K983602 CV PERI-GUARD AND VASCU-GUARD Bio-Vascular, Inc. DXZ Class II 1998-11-12
K983771 STRATEGY CORONARY WIRE GUIDE Cook, Inc. DQX Class II 1998-11-12
K983033 ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE Guidant Corp. DQX Class II 1998-11-10
K982975 DIGITAL ECG HOLTER RECORDER, MODEL DR512 Datrix MWJ Class II 1998-11-10
K982843 CMS-2000 Industrial Technology Research Institute MWJ Class II 1998-11-10
K982876 HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 Guidant Corp. DQX Class II 1998-11-10
K983632 SIEMENS SC 8000 BEDSIDE MONITOR Siemens Medical Solutions USA, Inc. DSI Class II 1998-11-06
K983684 DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS Datex-Ohmeda, Inc. DQA Class II 1998-11-06
K983287 MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE Graphic Controls Corp. MKJ Class III 1998-11-05
K971616 BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) Data Sciences Intl., Inc. DQO Class II 1998-11-04
K981378 DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 Datex-Engstrom, Inc. DRT Class II 1998-11-03
K982776 9303 NEONATAL/ADULT VITAL SIGNS MONITOR Cas Medical Systems, Inc. DQA Class II 1998-11-02
K982835 ELECTRODE SWITCHBOX, MODEL 11-081002 Cardima, Inc. DRF Class II 1998-10-29
K974581 MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT Invivo Research, Inc. DRT Class II 1998-10-28
K982810 SHELHIGH NO-REACT VASCUPATCH Shelhigh, Inc. DXZ Class II 1998-10-28
K980977 PIOLAX HYDROPHILIC GUIDEWIRE Piolax Medical Devices, Inc. DQX Class II 1998-10-27
K981613 COBE SMARXT TUBING AND CONNECTORS Cobe Cardiovascular, Inc. DWE Class II 1998-10-26
K982255 MODEL 2000 PULSE OXIMETER Ivy Biomedical Systems, Inc. DQA Class II 1998-10-22
K982592 DOCKING-EXTENSION WIRE Schneider (Europe) GmbH DQX Class II 1998-10-21
K982896 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 Alexander Mfg. Co. LDD Class II 1998-10-21

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