meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
37
Latest Decision
1997-11-06

Clearances · page 111 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962359 LIFEPAK 300 Physio-Control Corp. MKJ Class III 1997-11-06
K962473 (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH Data Critical Corporation MSX Class II 1997-11-06
K972962 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 3M Company DRY Class II 1997-11-06
K973007 DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER Datascope Corp. DYB Class II 1997-11-06
K971928 QUEST VESSEL CATHETER Quest Medical, Inc. DWF Class II 1997-11-06
K963957 TRINITY DVT SYSTEM Delphi Consulting Group JOW Class II 1997-11-04
K970853 PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) Cardima, Inc. DRF Class II 1997-11-04
K972518 TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 1997-11-04
K972944 MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT Medtronics Interventional Vascular DQX Class II 1997-11-03
K971719 THEROX INFUSION GUIDEWIRES Therox, Inc. DQX Class II 1997-11-03
K964210 RETRIEVER II Target Therapeutics DQO Class II 1997-10-31
K963967 GLYCAR PERICARDIAL PATCH Glycar, Inc. DXZ Class II 1997-10-31
K963368 GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE Glycar, Inc. DXZ Class II 1997-10-31
K970638 CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT Cardiothoracic Systems, Inc. DXC Class II 1997-10-30
K971013 CHASE TEMPERATURE PROBE Chase Medical, Inc. DTN Class II 1997-10-28
K970264 CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM Cordis Webster, Inc. DYB Class II 1997-10-28
K972829 CRICKET 2000 RECORDING PULSE OXIMETER Respironics, Inc. DQA Class II 1997-10-28
K971265 VIKING DIAGNOSTIC ELECTRODE CATHETER C.R. Bard, Inc. DRF Class II 1997-10-23
K962783 EDEMA SYSTEM Bioanalogics, Inc. DSB Class II 1997-10-23
K972880 MDP2000 MEDICAL DATA PROCESSOR Vidco, Inc. MSX Class II 1997-10-22
K971683 WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET Marquette Electronics, Inc. MSX Class II 1997-10-22
K972978 VISTA BRITE TIP GUIDING CATHETERS Cordis Corp. DQY Class II 1997-10-21
K972837 NPB-290 PULSE OXIMETER (NPB-290) Nellcor Puritan Bennett, Inc. DQA Class II 1997-10-21
K972746 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 Alexander Mfg. Co. DPS Class II 1997-10-21
K971436 NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES Nihon Kohden America, Inc. LDD Class II 1997-10-21
K972714 SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 1997-10-17
K972787 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P Alexander Mfg. Co. DRT Class II 1997-10-17
K972789 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 Alexander Mfg. Co. DRT Class II 1997-10-17
K972786 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 Alexander Mfg. Co. DQA Class II 1997-10-17
K962829 HARMAC BALLOON ANGIOGRAPHIC CATHETER Harmac Medical Products, Inc. DQO Class II 1997-10-16
K963335 HARMAC BALLOON WEDGE PRESSURE CATHETER Harmac Medical Products, Inc. DQO Class II 1997-10-16
K970741 POWERHEART AECD Cardiac Science, Inc. MKJ Class III 1997-10-16
K962833 HARMAC TEMPORARY PACING CATHETER WITH BALLOON Harmac Medical Products, Inc. LDF Class II 1997-10-15
K972762 CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES Cardio Metrics, Inc. DQX Class II 1997-10-14
K972684 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM Innerdyne, Inc. DYB Class II 1997-10-10
K965112 MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS Medline Industries, Inc. DQO Class II 1997-10-10
K971628 SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) Somanetics Corp. DQA Class II 1997-10-10
K971281 RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE Medcomp DQX Class II 1997-10-09
K971712 COEUR 130 ML ANGIOGRAPHIC SYRINGE Coeur Laboratories, Inc. DXT Class II 1997-10-08
K970233 GELBFISH ENDO-VAC SYSTEM Gary A. Gelbfish MCW Class II 1997-10-08
K972654 MANIFOLD Medical Specialties Intl., Inc. DTL Class II 1997-10-08
K971273 INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF Bio-Tek Instruments, Inc. DQA Class II 1997-10-08
K971877 LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR Dideco S.P.A. DTZ Class II 1997-10-08
K971131 FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. DSI Class II 1997-10-03
K970570 NIVP3 (WINDOWS VERSION OF NIVP D. E. Hokanson, Inc. DQK Class II 1997-10-03
K972525 THUMPER Michigan Instruments, Inc. DRM Class II 1997-10-02
K972570 HEARTPORT INTRODUCER SHEATH Heartport, Inc. DYB Class II 1997-10-01
K970854 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER Cordis Corp. DQO Class II 1997-09-30
K964043 COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS Cobe Cardiovascular, Inc. DTZ Class II 1997-09-29
K961848 3M LITTMANN ELECTRONIC STETHOSCOPE Minnesota Mining and Mfg. Co. DQD Class II 1997-09-26
K972484 ACS VIKING GUIDING CATHETER Guidant Corp. DQY Class II 1997-09-26
K972282 SPACELABS MEDICAL PCIS PATIENT MONITORS Spacelabs Medical, Inc. DSI Class II 1997-09-25
K972199 SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS Marquette Electronics, Inc. DPS Class II 1997-09-25
K972468 NPB-195 PULSE OXIMETER Nellcor Puritan Bennett, Inc. DQA Class II 1997-09-25
K972418 HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) Heartstream, Inc. MKJ Class III 1997-09-25
K970061 ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) Datascope Corp. DQA Class II 1997-09-25
K972378 SANAPHON N Rudolf Riester GmbH & Co. KG DXQ Class II 1997-09-24
K972379 PRECISA N Rudolf Riester GmbH & Co. KG DXQ Class II 1997-09-24
K972377 RI-MEGA Rudolf Riester GmbH & Co. KG DXQ Class II 1997-09-24
K971038 KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE Kontron Instruments , Ltd. DPS Class II 1997-09-24
K963071 ANGIOMAT ILLUMENA Mallinckrodt Inc., Liebel-Flarsheim Business DXT Class II 1997-09-23
K964467 SHELHIGH PERICARDIAL PATCH Shelhigh, Inc. DXZ Class II 1997-09-23
K971984 AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) Microvena Corp. MCW Class II 1997-09-19
K971569 DINAMAP MPS PORTABLE MONITOR Johnson & Johnson Medical, Inc. MSX Class II 1997-09-19
K972301 BIG BEN SQUARE, BIG BEN ROUND Rudolf Riester GmbH & Co. KG DXQ Class II 1997-09-17
K972290 ACS HI-TORQUE RULER GUIDE WIRE Guidant Corp. DQX Class II 1997-09-17
K963865 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S Arrow Intl., Inc. DSP Class II 1997-09-16
K972261 RIVETTI-LEVINSON INSTRALUMINAL SHUNT Integra Neurocare, LLC DWF Class II 1997-09-15
K960884 TELE TRENS TM 10 Life Sensing Instrument Company, Inc. DSI Class II 1997-09-12
K972320 BIOZ SYSTEM & BIOZ PORTABLE Cardiodynamics International Corp. DSB Class II 1997-09-11
K964624 SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 1997-09-11
K963725 MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED) Card Guard , Ltd. DXH Class II 1997-09-10
K972017 BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) Minntech Corp. DTN Class II 1997-09-10
K971520 S3 CYCLIC RPM CONTROL Stoeckert Instrumente DWB Class II 1997-09-10
K970585 FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR Fukuda Denshi USA, Inc. DSI Class II 1997-09-09
K971023 CHASE THORACIC CATHETER Chase Medical, Inc. DWF Class II 1997-09-08
K964238 AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS Aircast, Inc. JOW Class II 1997-09-08
K973222 SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER Siemens Medical Solutions USA, Inc. DQA Class II 1997-09-04
K964908 VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER Sorin Biomedical, Inc. DTN Class II 1997-09-03
K972113 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL Boston Scientific Corp DSP Class II 1997-09-02
K970347 MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM Paladin Medical, Inc. DTE Class II 1997-08-29
K970072 OPUS S MODEL 4121 AND 4124 PACEMAKERS Ela Medical, Inc. DXY Class III 1997-08-29
K970296 ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER Boston Scientific Corp MCW Class II 1997-08-29
K970769 COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR Aristo Medical DQA Class II 1997-08-28
K972175 INFUSASLEEVE IIA (IS-2A) Localmed, Inc. QEY Class II 1997-08-28
K972970 MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE Graphic Controls Corp. MKJ Class III 1997-08-27
K972503 CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE Sorin Group Italia S.R.L. DWF Class II 1997-08-26
K972142 ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING Guidant Corp. DQX Class II 1997-08-25
K971946 NPB-190 PULSE OXIMETER (NPB-190) Nellcor Puritan Bennett, Inc. DQA Class II 1997-08-25
K972665 CHASE BLOOD VESSEL SHUNT Chase Medical, Inc. DWF Class II 1997-08-22
K964907 VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT Sorin Biomedical, Inc. DTN Class II 1997-08-21
K970298 DM-400 HOLTER ECG CASSETTE RECORDER Diagnostic Monitoring DSH Class II 1997-08-20
K972310 NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH Nihon Kohden America, Inc. DPS Class II 1997-08-20
K970611 ORIGIN CARDIAC STABLIZER OCCLUDER Origin Medsystems, Inc. DXC Class II 1997-08-19
K965140 CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM Cardio Metrics, Inc. DQX Class II 1997-08-18
K970182 DINAMAP COMPACT MONITOR Johnson & Johnson Medical, Inc. MHX Class II 1997-08-18
K970348 SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER Siemens Medical Solutions USA, Inc. DSI Class II 1997-08-15
K970305 PRINTER INTERFACE Micromedical, Inc. DXH Class II 1997-08-15
K972110 Cordis Endeavor Infusion Catheter Cordis Corp. QEY Class II 1997-08-14
K963073 HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET Harmac Medical Products, Inc. LDF Class II 1997-08-14

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