meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1999-07-28

Clearances · page 106 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K992197 MODIFICATION TO ZYMED HOLTER 2000 Zymed Medical Instrumentation MLO Class II 1999-07-28
K984627 AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER Arterial Vascular Engineering, Inc. DQO Class II 1999-07-27
K990823 PVS 1400 GUIDEWIRE Precision Vascular Systems, Inc. DQX Class II 1999-07-23
K992231 FOUNTAIN Infusion Catheter and Occluding Guide Wire Merit Medical Systems, Inc. QEY Class II 1999-07-23
K990476 HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION Hewlett-Packard GmbH MHX Class II 1999-07-22
K991557 MEDRAD VISTRON CT INJECTOR SYSTEM Medrad, Inc. DXT Class II 1999-07-21
K992328 FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 Meditec Co., Ltd. DXN Class II 1999-07-21
K992142 SCIMED ANGIOGRAPHIC CATHETERS Scimed DQO Class II 1999-07-21
K991525 DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF Deroyal Industries, Inc. DXQ Class II 1999-07-20
K991367 MEDITRON STETHOSCOPE SYSTEM Meditron AS DQD Class II 1999-07-19
K991001 MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER Ep Medsystems DRF Class II 1999-07-15
K983940 EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR Adam Spence Corp. DYB Class II 1999-07-15
K990068 SOLAR 9500 INFORMATION MONITOR General Electric Medical Systems Information Techn MHX Class II 1999-07-14
K991602 EPTFE RINGED GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1999-07-09
K991211 EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM Reynolds Medical , Ltd. DXH Class II 1999-07-08
K984033 ATLAS MONITOR Welch Allyn, Inc. DRT Class II 1999-07-08
K991170 RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 Edwards Lifesciences Research Medical DWF Class II 1999-07-02
K991169 SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 Biotronik, Inc. DTB Class III 1999-07-01
K984586 FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS Fresenius Hemotechnology, Inc. DTN Class II 1999-06-29
K990705 MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET Medamicus, Inc. DYB Class II 1999-06-28
K990771 6F HYDROLYSER THROMBECTOMY CATHETER Cordis Corp. QEZ Class II 1999-06-25
K991775 MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS Mennen Medical, Inc. DXG Class II 1999-06-24
K982467 CAPIOX CARDIOPLEGIA Terumo Medical Corp. DTR Class II 1999-06-23
K974683 NAVIPORT DEFLECTABLE TIP GUIDING CATHETER Cardima, Inc. DQY Class II 1999-06-22
K991898 ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE Microvena Corp. DQX Class II 1999-06-16
K991811 CORDIS MAXI DS PTA BALLOON CATHETER Cordis Corp. LIT Class II 1999-06-15
K991307 TELEMEDICINE 2000 Card Guard Scientific Survival , Ltd. DXH Class II 1999-06-14
K990956 BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 Biosensor Corp. DQK Class II 1999-06-14
K991831 BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 Boston Medical Technologies, Inc. DPS Class II 1999-06-11
K982448 CARDIOLIGHT Capintec, Inc. DSH Class II 1999-06-11
K983791 PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA Edwards Lifesciences Research Medical DWF Class II 1999-06-11
K991102 COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 Guidant Corp. DTL Class II 1999-06-09
K990809 CADISCOPE ELECTRONIC STETHOSCOPE Caditec AG DQD Class II 1999-06-09
K991410 3402 HANDHELD PULSE OXIMETER Bci Intl., Inc. DQA Class II 1999-06-09
K991619 FOUNTAIN Infusion Catheter and Occluding Guide Wire Merit Medical Systems, Inc. QEY Class II 1999-06-09
K990795 MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES Cardiac Pathways Corp. MTD Class II 1999-06-08
K990966 MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS Masimo Corp. DQA Class II 1999-06-07
K991773 HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P Hewlett-Packard GmbH DSI Class II 1999-06-07
K990483 RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 Biotronik, Inc. DTB Class III 1999-06-03
K983996 SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM Spacelabs Medical, Inc. MHX Class II 1999-06-03
K990958 ORTHOGONAL EP CATHETERS Irvine Biomedical, Inc. DRF Class II 1999-06-03
K991688 WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S Jawon Medical Co., Ltd. DXN Class II 1999-06-01
K991813 UNI-GRAFT K DV VASCULAR GRAFT Atrium Medical Corp. DSY Class II 1999-06-01
K991661 SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER Siemens Medical Solutions USA, Inc. DQA Class II 1999-05-28
K991673 CORDIS TEMPO ANGIOGRAPHY CATHETER Cordis Corp. DQO Class II 1999-05-26
K990239 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. DTN Class II 1999-05-25
K973592 WALKCARE P200 SYSTEM A.Stein - Regulatory Affairs Consulting JOW Class II 1999-05-20
K973078 WRIST BLOOD PRESSURE METER MODEL SE-330 Sein Electronics Co., Ltd. DPW Class II 1999-05-20
K991589 FLEXIBLE VASCULAR CLAMP, VERSION 2 Allegiance Healthcare Corp. DXC Class II 1999-05-18
K983575 ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX Datascope Corp. DXN Class II 1999-05-13
K972803 TRACER O-T-W MAPPING DEVICE Cardima, Inc. DRF Class II 1999-05-11
K990093 ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW Agilent Technologies DSI Class II 1999-05-11
K983039 EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF Schneider/Namic DYB Class II 1999-05-07
K991194 MODIFICATION TO ULTRA-SELECT GUIDEWIRE Microvena Corp. DQX Class II 1999-05-05
K983393 LIFEPAK 500 BIPHASIC Physio-Control Corp. MKJ Class III 1999-05-05
K990829 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 Arrow Intl., Inc. MCW Class II 1999-05-04
K991152 HI-TORQUE BALANCE TREK GUIDE WIRE Guidant Corp. DQX Class II 1999-04-29
K983680 TRINITY II SINGLE CHAMBER DVT PUMP Delphi Consulting Group JOW Class II 1999-04-28
K984223 BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 Citizen Watch Co., Ltd. DXN Class II 1999-04-28
K981311 COWBOY XV Kci New Technologies, Inc. JOW Class II 1999-04-23
K991027 BI-DIRECTIONAL TUNNELER Impra, Inc. DSY Class II 1999-04-22
K983456 ENSITE 3000 SYSTEM Endocardial Solutions, Inc. MTD Class II 1999-04-21
K981995 QUICKDRAW VENOUS CANNULA Heartport, Inc. DWF Class II 1999-04-20
K990972 HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T Hewlett-Packard GmbH DSI Class II 1999-04-19
K983830 COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER Mallinckroot, Inc. LIT Class II 1999-04-16
K990170 HOLTER 2000 Zymed Medical Instrumentation MLO Class II 1999-04-13
K990123 PVR-100/VASOGRAM Vasocor, Inc. JOM Class II 1999-04-12
K983102 CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 Cambridge Heart, Inc. DQK Class II 1999-04-12
K982617 TRACER Heartland Medical Systems, Inc. MWJ Class II 1999-04-09
K990082 EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 Epic Medical Equipment Services, Inc. DQA Class II 1999-04-09
K982365 ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT Geister Medizin Technik GmbH DXC Class II 1999-04-08
K984526 ACUSEAL CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. DXZ Class II 1999-04-08
K981191 ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 Intratherapeutics, Inc. DQY Class II 1999-04-07
K990726 ENVY GUIDING CATHETER Cook, Inc. DQY Class II 1999-04-02
K982641 ADVANCED NIBP MODULE Johnson & Johnson Medical, Inc. DXN Class II 1999-03-29
K982278 MICRINS MICRO ANASTOMOSIS CLAMP Micrins Surgical, Inc. DXC Class II 1999-03-26
K984618 BCI MINI-TORR PLUS, MODEL 6004 Bci Intl., Inc. DXN Class II 1999-03-25
K990639 ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING. Guidant Corp. DQX Class II 1999-03-25
K984062 SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 Diag Corp. DYB Class II 1999-03-24
K982136 JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 Schiff & Co. DTN Class II 1999-03-24
K983272 IBC FLOPUMP, MODEL 6000 International Biophysics Corp. KFM Class II 1999-03-24
K983346 STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF Guidant Corp. DQX Class II 1999-03-23
K990772 DIRECTFLOW ARTERIAL CANNULA Heartport, Inc. DWF Class II 1999-03-23
K990707 MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS Medtronics Interventional Vascular DQY Class II 1999-03-22
K974393 VASO PRESS SYSTEM Britt Corp., Inc. JOW Class II 1999-03-19
K990563 SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION Siemens Medical Solutions USA, Inc. MHX Class II 1999-03-19
K984582 ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX Bio-Detek, Inc. MKJ Class III 1999-03-16
K980688 INTEGRITI PATIENT MONITOR Alliance Instruments MWI Class II 1999-03-16
K990805 MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER Cordis Corp. QEZ Class II 1999-03-15
K984418 UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET Medrad, Inc. DXT Class II 1999-03-11
K983171 CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM Boston Scientific Corp MTD Class II 1999-03-11
K982992 ZOLL M SERIES SPO2 OPTION Zoll Medical Corp MKJ Class III 1999-03-11
K983927 GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT Arterial Vascular Engineering, Inc. DQT Class II 1999-03-11
K990573 ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA Estech, Inc. DXC Class II 1999-03-11
K990514 MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR C.R. Bard, Inc. DTP Class II 1999-03-09
K984271 MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 Medtronic Vascular DTZ Class II 1999-03-09
K984394 ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING Guidant Corp. DQX Class II 1999-03-08
K981702 AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1999-03-05
K981542 PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 Panasonic Corporation (Panasonic) DXN Class II 1999-03-03
K981431 PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280 Panasonic Corporation (Panasonic) DXN Class II 1999-03-03

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