meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1998-10-19

Clearances · page 108 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K982299 SPYGLASS 5 FR ANGIOGRAPHIC CATHETER Daig Corp. DQO Class II 1998-10-19
K974774 ENVY GUIDING CATHETER Cook, Inc. DQO Class II 1998-10-16
K981660 Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters C.R. Bard, Inc. DSP Class II 1998-10-16
K982220 MODEL 2872 BIPOLAR LEAD ADAPTOR KIT Medtronic Vascular DTD Class II 1998-10-15
K973198 VGF-7 VASCULAR GRAFT FLOWMETER Medicard , Ltd. DPW Class II 1998-10-14
K981697 CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM Cambridge Heart, Inc. DPS Class II 1998-10-14
K981119 CARDIOPAL MODEL NUMBER PM20 Medicomp, Inc. DXH Class II 1998-10-14
K974713 BARD HYDROPHILLIC COATED GUIDE WIRE C.R. Bard, Inc. DQX Class II 1998-10-14
K982470 ECG ELECTRODES APRON Tapuz Medical Technology , Ltd. DRX Class II 1998-10-14
K982814 MEDRAD VISTRON CT INJECTOR SYSTEM Medrad, Inc. DXT Class II 1998-10-09
K982406 COBE VACUUM RELIEF CHECK VALVE Cobe Cardiovascular, Inc. MJJ Class II 1998-10-07
K980186 ZYMED TELEMETRY SYSTEM Agilent Technologies DSI Class II 1998-10-07
K973970 SPO2 FINGER PROBES Medical Cables, Inc. DQA Class II 1998-10-06
K982538 BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP Belmont Instrument Corp. DSP Class II 1998-10-02
K982907 MAGNATEK 40 Magna Advanced Technologies, Inc. DQA Class II 1998-10-02
K983023 MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. DYB Class II 1998-10-01
K982891 CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS California Medical Laboratories, Inc. DTS Class II 1998-09-30
K981394 BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 Braemar Corp. DXH Class II 1998-09-28
K982279 VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 Bci Intl., Inc. MHX Class II 1998-09-25
K982481 A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 1998-09-25
K973637 PRESS-MATE ADVANTAGE Colin Medical Instruments Corp. DXN Class II 1998-09-25
K982817 EWC: ECG CABLE AND LEADWIRE SYSTEMS Ewc DSA Class II 1998-09-23
K982182 FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 Radi Medical Systems AB DXC Class II 1998-09-18
K982405 MTEK-1000 Magna Advanced Technologies, Inc. DQA Class II 1998-09-17
K983003 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS Cordis Neurovascular, Inc. KRA Class II 1998-09-17
K982187 FAST-CATH INTRA-CARDIAC INTRODUCER Daig Corp. DYB Class II 1998-09-16
K982135 OSCILLOMATE EMS NIBP MONITOR MODEL 9001 Cas Medical Systems, Inc. DXN Class II 1998-09-15
K982331 KELLER PULSE OXIMETER, MODEL 850+ Keller Medical Specialties Products, Inc. DQA Class II 1998-09-11
K980578 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) Innerdyne, Inc. DYB Class II 1998-09-11
K982083 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. DQX Class II 1998-09-11
K982223 CAPIOX SX HARDSHELL RESEVOIR Terumo Medical Corp. DTN Class II 1998-09-10
K980869 SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 Biotronik, Inc. DTB Class III 1998-09-10
K982254 COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD Cobe Cardiovascular, Inc. DTM Class II 1998-09-10
K980429 HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) Hewlett-Packard Co. DSI Class II 1998-09-09
K982883 MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1998-09-04
K982014 STOCKERT COMPACT SYSTEM Stoeckert Instrumente DTQ Class II 1998-09-04
K981009 HEARTPORT ENDOPULMONARY VENT CATHETER Heartport, Inc. DWF Class II 1998-09-04
K982025 HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR Hewlett-Packard Co. MKJ Class III 1998-09-04
K973477 BIOSENSORS EMBOLECTOMY CATHETER Sunscope Intl., Inc. DXE Class II 1998-09-04
K980762 PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE Pall Corp. DTM Class II 1998-09-01
K982141 ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 Arrow Intl., Inc. DXE Class II 1998-08-31
K982740 CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S Cordis Webster, Inc. DYB Class II 1998-08-28
K972689 CAOW HEMOSTASIS SYSTEM Anlam Corp. DXC Class II 1998-08-27
K982707 EC6 PLETHYSMOGRAPH D. E. Hokanson, Inc. JOM Class II 1998-08-26
K973751 MT-200 Schiller America, Inc. DQK Class II 1998-08-25
K974220 MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE Micromedical, Inc. DPS Class II 1998-08-25
K973735 MICROVIT MT-100 Schiller America, Inc. DSH Class II 1998-08-25
K982730 SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR Siemens Medical Solutions USA, Inc. DSI Class II 1998-08-24
K980786 COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 Cobe Cardiovascular, Inc. DTN Class II 1998-08-24
K980390 PTA BALLOON CATHETER Cook, Inc. LIT Class II 1998-08-20
K981747 BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX Sunscope Intl., Inc. DRS Class II 1998-08-20
K980619 SABRATEK PATIENT HOME MANAGEMENT SYSTEM Sabratek Corp. MHX Class II 1998-08-20
K980411 NPB3900 SERIES PATIENT MONITORS Analogic Corp. MHX Class II 1998-08-20
K981939 AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR Bci Intl., Inc. DQA Class II 1998-08-20
K963271 FUTREX-6100/XL Futrex, Inc. MNW Class II 1998-08-19
K981807 CARDIOVISION SOFTWARE, MODEL S-CV5-96 Shl Telemedicine International , Ltd. DPS Class II 1998-08-19
K982632 ENVOY AND VISTA BRITE TIP Cordis Corp. DQY Class II 1998-08-18
K981788 SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. DQO Class II 1998-08-18
K982770 6F ENVOY GUIDING CATHETER Cordis Corp. DQY Class II 1998-08-18
K982342 DINAMAP MPS SELECT PORTABLE MONITOR Critikon Company, LLC MSX Class II 1998-08-14
K982697 MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR Mennen Medical, Inc. DSI Class II 1998-08-12
K981284 BETTER-BLADDER (BB) Circulatory Technology, Inc. DTN Class II 1998-08-12
K981782 LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM Arrow Intl., Inc. DYB Class II 1998-08-12
K980600 D903 AVANT ADULT HOLLOW FIBER OXYGENATOR Dideco S.P.A. JOW Class II 1998-08-12
K973426 ANS 2000 ECG MONITOR AND RESPIRATION PACER D. E. Hokanson, Inc. DPS Class II 1998-08-12
K982077 SELECTOR DIAGNOSTIC CATHETER Boston Scientific Scimed, Inc. DQO Class II 1998-08-11
K980453 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. DQY Class II 1998-08-11
K982415 CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 Cordis Webster, Inc. DRF Class II 1998-08-10
K982710 AECD ARRHYTHMIA DETECTION SOFTWARE Cardiac Science, Inc. MKJ Class III 1998-08-10
K980504 EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET Schneider/Namic DYB Class II 1998-08-07
K973705 CONTOR TABLE SURFACE Hill-Rom, Inc. DWJ Class II 1998-08-07
K980016 MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE Genzyme Surgical Product (Genzyme Biosurgery) MOP Class I 1998-08-07
K981198 MEDTRONIC ZUMA GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1998-08-07
K971892 BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 Biomedical Horizons, Inc. JOW Class II 1998-08-05
K961798 CT 200 ELECTROCARDIOGRAPH Macquarie Medical Systems DPS Class II 1998-08-05
K981642 STABLEMAPR STEERABLE INTRACARDIAC CATHETERS Medtronic Cardiorhythm DRF Class II 1998-08-05
K981628 BARD QUANTUM SVR MODEL NUMBER H-6440VR C.R. Bard, Inc. DTN Class II 1998-08-05
K974648 SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR Sulzer Carbomedics, Inc. MOP Class I 1998-08-04
K981624 FLO-THRU Bio-Vascular, Inc. DXC Class II 1998-08-04
K981601 CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER Sorin Group Italia S.R.L. DWF Class II 1998-07-28
K981951 CT 100 ELECTROCARDIOGRAPH Macquarie Medical Systems DPS Class II 1998-07-28
K974445 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 3M Healthcare DRX Class II 1998-07-26
K982232 MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM Irvine Biomedical, Inc. DRF Class II 1998-07-25
K980128 BALADI INVERTER WITH COAXIAL AORTIC PUNCH Cardio Medical Solutions, Inc. DXC Class II 1998-07-24
K981083 RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 Biotronik, Inc. DTB Class III 1998-07-22
K971322 CORE AND COIL ASSEMBLY GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 1998-07-22
K981576 MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A Hewlett-Packard GmbH MHX Class II 1998-07-17
K981745 BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX Sunscope Intl., Inc. DRS Class II 1998-07-17
K981417 Squirt Fluid Delivery System Merit Medical Systems, Inc. QEY Class II 1998-07-17
K980879 OSCILLOMATE NIBP / SP02 EMS MONITOR Cas Medical Systems, Inc. DQA Class II 1998-07-16
K981381 ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1 Guidant Corp. DQX Class II 1998-07-15
K981533 AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 American Telecare, Inc. DRG Class II 1998-07-15
K974736 HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER Heartport, Inc. DWF Class II 1998-07-15
K981326 LAKE REGION MANUFACTURING GUIDEWIRES Lake Region Mfg., Inc. DQX Class II 1998-07-10
K981441 HEART CATH TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. DQO Class II 1998-07-10
K981956 DEGANIA SILICONE IDENTI LOOPS Degania Silicone , Ltd. DXC Class II 1998-07-09
K974698 SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS Siemens Medical Solutions USA, Inc. DSI Class II 1998-07-08
K980487 CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM Baxter Edwards KRH Class II 1998-07-07
K972899 CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER Cypress Medical Products, Ltd. DXQ Class II 1998-07-07
K971975 CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER Cardima, Inc. DRF Class II 1998-07-01

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