meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
1995-04-19

Clearances · page 121 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K943257 TIP DEFLECTOR (GENESIS) Electro-Catheter Corp. DRF Class II 1995-04-19
K950615 KAPLAN-SIMPSON INFUSASLEEVE CATHETER Localmed, Inc. QEY Class II 1995-04-19
K946272 SCIMED(R) COURIER GUIDE CATHETER Scimed Peripheral Interventions DQY Class II 1995-04-17
K950266 SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-04-14
K950316 CORDIS STEERABLE GUIDEWIRES Cordis Corp. DQX Class II 1995-04-14
K940009 GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 General Devices DRG Class II 1995-04-14
K950069 DASHER-14 Target Therapeutics DQX Class II 1995-04-12
K940081 MERCURY Mennen Medical, Inc. DRT Class II 1995-04-12
K945130 BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER Braemar Corp. DSH Class II 1995-04-12
K940323 ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM Arbo Medical, Inc. DSA Class II 1995-04-12
K933177 SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS Siemens Medical Solutions USA, Inc. DSI Class II 1995-04-10
K944350 SC 6000/ SC 6000P/ R50 Siemens Medical Solutions USA, Inc. DSI Class II 1995-04-10
K935043 SIEMENS CLINICAL WORK STATION Siemens Medical Electronics DQK Class II 1995-04-07
K935437 ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES Arbo Medical, Inc. DRX Class II 1995-04-06
K934975 TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER Rlt Medical Assoc., Inc. DXH Class II 1995-04-06
K940298 BSC/CA MODEL 940 IAB Boston Scientific Corp DSP Class II 1995-04-06
K941916 QUEST CORONARY SINUS PERFUSION CANNULA -FRCC Quest Medical, Inc. DWF Class II 1995-04-06
K950140 IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 Pacesetter, Inc. DTD Class II 1995-04-06
K950026 MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1995-04-05
K950047 SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER Isomedix Operations, Inc. DQY Class II 1995-04-05
K951129 NOVATRANS II Medex, Inc. DRS Class II 1995-04-05
K950731 SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. DQO Class II 1995-04-05
K950156 ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1995-04-05
K943931 CARRYALL ENHANCEMENTS Instromedix, Inc. DXH Class II 1995-04-04
K944844 BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT Baxter Healthcare Corp DYF Class II 1995-03-31
K946356 M-PATH NITINOL GUIDEWIRE Microvena Corp. DQX Class II 1995-03-31
K946240 SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-03-31
K950113 SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-03-31
K950141 SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-03-31
K945616 CORDIS AVANTI CATHETER SHEATH INTRODUCER Cordis Corp. DYB Class II 1995-03-29
K945720 JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE Jostra Bentley DWC Class II 1995-03-29
K942796 PRESSSION S III Chattanooga Group, Inc. JOW Class II 1995-03-24
K943842 PULSE OXIMETER MODEL 305 Palco Laboratories, Inc. DQA Class II 1995-03-24
K943919 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER Boston Scientific Corp DSP Class II 1995-03-23
K945037 SIEMENS 1481 T TRANSMITTER, ENHANCED Siemens Medical Solutions USA, Inc. DRG Class II 1995-03-21
K946180 SCIMED(R) ENTRE PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-03-17
K942381 LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING Apogee, Inc. DXT Class II 1995-03-17
K946185 3301T OXITEMP Bci Intl., Inc. DQA Class II 1995-03-17
K946205 CARDIOVIT AT-1, P-80 Schiller America, Inc. DPS Class II 1995-03-16
K933278 INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 Intermedics, Inc. KRG Class III 1995-03-15
K950778 MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER Shanghai Medifriend Medical Products Co., Ltd. DXQ Class II 1995-03-14
K942344 ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR Zoll Medical Corp MKJ Class III 1995-03-13
K945396 FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET B.Braun Medical, Inc. DYB Class II 1995-03-13
K946204 SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS Scimed Life Systems, Inc. DQY Class II 1995-03-13
K943242 PRO-SPORT HEART RATE MONITOR Sensor Dynamics, Inc. DRT Class II 1995-03-10
K943243 PULSE HEART RATE MONITOR Sensor Dynamics, Inc. DRT Class II 1995-03-10
K945947 NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER Nellcor, Inc. DXN Class II 1995-03-08
K943995 IMD PSD 410 PACEMAKER TRANSMITTER Integrated Medical Devices, Inc. DXH Class II 1995-03-07
K945931 RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE Research Industries Corp. DTL Class II 1995-03-03
K944668 SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS Medtronics Interventional Vascular DQY Class II 1995-03-03
K946052 POWERFLEX(TM) 5F PTA BALLOON CATHETER Cordis Corp. LIT Class II 1995-03-03
K944284 CONTROL Daig Corp. DQO Class II 1995-03-03
K945129 SCIMED CHIOCE PLUS PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-03-03
K950094 SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER Scimed Life Systems, Inc. DQY Class II 1995-03-03
K946115 EK-VIEW(TM) ECG MANAGEMENT SYSTEM Apcot Medical Systems DXG Class II 1995-03-01
K950635 CANDEKA DUKATIR SETS Candela Laser Corp. DQY Class II 1995-03-01
K950634 CANDELA SHEATH SETS Candela Laser Corp. DQY Class II 1995-03-01
K942700 DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 Critikon Company, LLC MHX Class II 1995-03-01
K932903 EKG VEST Cardiotronics, Inc. DRX Class II 1995-02-24
K946029 ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT Advanced Cardiovascular Systems, Inc. DQX Class II 1995-02-24
K945943 CVD PERIFLOW(TM) BALLOON DILATATION CATHETER Cardio-Dynamics, Inc. LIT Class II 1995-02-24
K934787 SILICORE SEMI-FLOATER Electro-Catheter Corp. LDF Class II 1995-02-24
K942454 DATASCOPE 95 AND 97 IAB PUMP CONSOLE Datascope Corp. DSP Class II 1995-02-24
K940264 VASOGENICS EECP-MC2 Vasogenics, Inc. DRN Class II 1995-02-23
K941762 INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) Hogan & Hartson DQK Class II 1995-02-22
K943736 CVPRO CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. DXZ Class II 1995-02-22
K933522 INTRODUCER NEEDLE (SEVERAL SIZES) Mediziv Medical Products 1987 , Ltd. DYB Class II 1995-02-21
K941922 MEDSAT OXYGEN SATURATION SYSTEM Medtronic Bio-Medicus, Inc. DRY Class II 1995-02-17
K942842 HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE Hewlett-Packard GmbH DQA Class II 1995-02-16
K942423 NAIS WRIST BLOOD PRESSURE METER King & Spalding DXN Class II 1995-02-15
K942422 PANASONIC WRIST BLOOD PRESSURE METER King & Spalding DXN Class II 1995-02-15
K924972 SONAMET BODY COMPOSITION ANALYZER Life Measurement Instruments, Inc. OAC Class II 1995-02-13
K942850 ZOLL POWERBASE(TM) Zoll Medical Corp MKJ Class III 1995-02-10
K943597 MONARCH AP(TM) Merit Medical Systems, Inc. MAV Class II 1995-02-10
K944214 BAXTER HANDLE MODEL 1150 Baxter Edwards DTJ Class I 1995-02-10
K935184 REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING St. Jude Medical, Inc. DSP Class II 1995-02-10
K940445 VIVALINK AED DEFIBRILLATOR Survivalink Corp. MKJ Class III 1995-02-09
K945963 THE OMNIGUIDE GUIDING CATHETER WITH BALLOON Micro Interventional Systems, Inc. DQT Class II 1995-02-08
K944677 SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES Scimed Peripheral Interventions DQX Class II 1995-02-08
K942457 GRAFT THROMBECTOMY INSTRUMENTS Intramed Laboratories, Inc. MCW Class II 1995-02-07
K943301 QUIK COMBO Physio-Control Corp. DRX Class II 1995-02-03
K945705 5F ENVOY(TM) GUIDING CATHETER Cordis Neurovascular, Inc. DQY Class II 1995-02-03
K945461 PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) Medtronics Interventional Vascular DTL Class II 1995-02-03
K945464 FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE Fukuda Denshi USA, Inc. DQA Class II 1995-02-01
K950249 VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205 Medwave, Inc. DXN Class II 1995-02-01
K945385 VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 Pace Tech, Inc. MHX Class II 1995-01-31
K945277 HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR Hewlett-Packard Co. DXJ Class II 1995-01-30
K942147 PACIFIC COMMUNICATIONS MODEL 1100 Accucore, Inc. DSI Class II 1995-01-30
K943081 TRIMLINE 2000 Pymah Corp. DXN Class II 1995-01-27
K942546 CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER Dynatech/Nevada, Inc. DXN Class II 1995-01-27
K942582 SORIN BLOOD CARDIOPLEGIA CONSOLE Sorin Biomedical, Inc. DTQ Class II 1995-01-27
K934692 K-DEFIB/PACE PEDIATRIC ELECTRODE Katecho, Inc. MKJ Class III 1995-01-24
K942790 WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) Cincinnati Sub-Zero Products, Inc. DWJ Class II 1995-01-24
K942781 DIGITAL HOLTER RECORDER Agilent Technologies DSH Class II 1995-01-24
K942599 WARM AIR WARMING UNIT Cincinnati Sub-Zero Products, Inc. DWJ Class II 1995-01-24
K942862 HEARTPRINT Medata, Inc. DSH Class II 1995-01-18
K942664 KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM The Kendal Co. JOW Class II 1995-01-17
K941166 QUEST CORONARY SINUS PERFUSION CANNULA Quest Medical, Inc. DWF Class II 1995-01-17
K945593 SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER Scimed Life Systems, Inc. KRA Class II 1995-01-13
K931020 HEART 1001 Aerotel, Ltd. DXH Class II 1995-01-11

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