meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
1996-11-08

Clearances · page 115 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963579 PACE-1A CARDIAC STIMULATOR Radionics, Inc. JOQ Class II 1996-11-08
K962180 CATH SEAL Universal Medical Instrument Corp. DYB Class II 1996-11-07
K963171 CINCH QR SGW EXTENSION Cordis Corp. DQX Class II 1996-11-07
K962366 HEARTPORT CABLE BULLDOG CLAMP Heartport, Inc. DXC Class II 1996-11-07
K961797 WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE Wright Linear Pump, Inc. JOW Class II 1996-11-06
K961292 WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL Wright Linear Pump, Inc. JOW Class II 1996-11-06
K961891 WLP SINGLE-SEGMENT VERSION WLP SOLO VII Wright Linear Pump, Inc. JOW Class II 1996-11-06
K961668 MICROFERRET CATHETER Cook, Inc. KRA Class II 1996-11-04
K955122 INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1996-11-04
K955854 LIFEPAK 500 Physio-Control Corp. MKJ Class III 1996-11-04
K963187 MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C Boston Scientific Corp DSP Class II 1996-11-04
K962668 AMR-ACV CLAMPS Applied Medical Resources DXC Class II 1996-11-04
K961836 MAXIMA FORTE HARDSHELL VENOUS RESERVOIR Medtronic Vascular DTN Class II 1996-11-01
K961364 AUTOMATIC TUBING CLAMP SYSTEM (ATC) Rocky Mountain Research, Inc. KRL Class II 1996-10-31
K962726 BARD QUANTUM CVR C.R. Bard, Inc. DTP Class II 1996-10-30
K954850 BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR C.R. Bard, Inc. DTZ Class II 1996-10-30
K961598 ELS AUTOMATIC TUBING CLAMP SYSTEM Rocky Mountain Research, Inc. KRL Class II 1996-10-29
K961595 DEFIBRILLATOR ANALYZER, DELTA 1000 Netech Corp. DRL Class II 1996-10-29
K954788 EUREDUC PNEUMATIC DRAINAGE SYSTEM Eureduc JOW Class II 1996-10-28
K960968 MEDI-TRACE 200, MEDI-TRACE 200-30 Graphic Controls Corp. DRX Class II 1996-10-28
K962932 CORDIS STABILIZER PLUS XS Cordis Corp. DQX Class II 1996-10-25
K960486 KSEA MODEL 383320 20 ANGIOMAT Karl Storz Endoscopy DQI Class II 1996-10-25
K955923 MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL Graphic Controls Corp. MKJ Class III 1996-10-24
K955882 MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS Graphic Controls Corp. MKJ Class III 1996-10-24
K961247 AS/3 LIGHT MONITOR Datex Division Instrumentarium Corp. DPS Class II 1996-10-23
K962945 CORDIS OPTA PTA BALLOON CATHETER Cordis Corp. LIT Class II 1996-10-23
K960056 USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC C.R. Bard, Inc. DQO Class II 1996-10-23
K954651 ELECTRODE RECORDING CATHETER Boston Scientific Corp DRF Class II 1996-10-22
K952790 LOG-A-RYTHM MODEL 100 AND MODEL 1001 Nian-Crae, Inc. DRT Class II 1996-10-17
K961499 LAGUNA SOFTIP DIAGNOSTIC CATHETERS Boston Scientific Scimed, Inc. DQO Class II 1996-10-17
K962830 VISTA BRITE TIP CATHETERS Cordis Corp. DQY Class II 1996-10-17
K960479 ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER Arrow Intl., Inc. LDF Class II 1996-10-17
K960074 CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR Terumo Medical Corp. DTZ Class II 1996-10-16
K962805 SPYGLASS ANGIOGRAPHIC CATHETER Daig Corp. DQO Class II 1996-10-15
K962746 CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT Cordis Corp. DYB Class II 1996-10-11
K961368 TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT Vasamedics, LLC DPT Class II 1996-10-11
K961166 FLOWTRON EXCEL PUMP Hne Healthcare, Inc. JOW Class II 1996-10-11
K955712 USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING C.R. Bard, Inc. LDF Class II 1996-10-11
K962127 OHMEDA 3800 PULSE OXIMETER Ohmeda Medical DQA Class II 1996-10-10
K961165 HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A Hewlett-Packard Co. DSI Class II 1996-10-10
K962759 4F NYLEX ANGIOGRAPHIC CATHETER Cordis Corp. DQO Class II 1996-10-10
K961401 HP CATHSTATION - MODEL M1264B Hewlett-Packard Co. DPS Class II 1996-10-08
K955891 CARDIOVIEW TRANSTELEPHONIC SOFTWARE Micromedical, Inc. DPS Class II 1996-10-08
K962667 CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR Terumo Medical Corp. DTZ Class II 1996-10-07
K955685 RNS STERILE, DISPOSABLE CT BIOPSY TRAY Contour Fabricators of Florida, Inc. DXT Class II 1996-10-04
K962639 IMPRA CARBOFLO EPTFE VASCULAR GRAFT Impra, Inc. DSY Class II 1996-10-03
K960418 EAGLE PATIENT MONITOR Marquette Electronics, Inc. DSI Class II 1996-10-02
K955827 DANESHVAR WOUND SUPPORT UNIT Y. Daneshvar DXC Class II 1996-10-02
K960272 EAGLE 3000/3100 PATIENT MONITOR Marquette Electronics, Inc. MLD Class II 1996-10-02
K961000 CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR Terumo Medical Corp. DTZ Class II 1996-10-02
K961107 B. BRAUN GUIDEWIRES B.Braun Medical, Inc. DQX Class II 1996-10-01
K962858 HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM Heartport, Inc. DXC Class II 1996-09-30
K950264 MAGLIFE Odam MHX Class II 1996-09-27
K953044 UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION Biotronik, Inc. DTB Class III 1996-09-27
K960902 EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03 Eureduc JOW Class II 1996-09-26
K961716 VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE Ideas For Medicine, Inc. DXE Class II 1996-09-19
K960674 CONTRAST INJECTION LINES B.Braun Medical, Inc. DXT Class II 1996-09-19
K953663 CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER Cordis Webster, Inc. DRF Class II 1996-09-18
K962307 RHYDER DIAGNOSTIC CATHETER Fidus Medical Technology Corp. DRF Class II 1996-09-17
K961745 BRAUN PERCUTANEOUS INTRODUCER SET B.Braun Medical, Inc. DYB Class II 1996-09-17
K962467 RV PACING LEAD Abbott Laboratories LDF Class II 1996-09-17
K962495 INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) Advanced Cardiovascular Systems, Inc. MAV Class II 1996-09-12
K961466 PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. DYB Class II 1996-09-12
K954168 E100A PULSE OXIMETER FINGER SENSOR/PROBE Epic Medical Equipment Services, Inc. DQA Class II 1996-09-12
K960965 FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 Coeur Laboratories, Inc. DXT Class II 1996-09-12
K961980 BIPORE BALLOON DILATATION CATHETER Bipore, Inc. LIT Class II 1996-09-12
K962510 HEARTPORT ENDOAORTIC CLAMP Heartport, Inc. DXC Class II 1996-09-11
K962342 HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH Meadox Medicals, Div. Boston Scientific Corp. DXZ Class II 1996-09-10
K954350 CARD GUARD MODEL CG-6500 Card Guard Scientific Survival , Ltd. DXH Class II 1996-09-10
K955628 FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS Heartstream, Inc. MKJ Class III 1996-09-10
K962266 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING Biocompatibles Cardiovascular, Inc. DQX Class II 1996-09-10
K952882 PERSONAL TELEMEDICINE SYSTEM American Telecare, Inc. DXN Class II 1996-09-09
K960715 PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F Ideas For Medicine, Inc. MJN Class II 1996-09-09
K961594 BETTER-VENTER Circulatory Technology, Inc. DWF Class II 1996-09-05
K955887 NEWMED ABP-LITE Newmed Corp. DXW Class II 1996-09-05
K962237 THUMPER CARDIOPULMONARY RESUSCITATOR Michigan Instruments, Inc. DRM Class II 1996-09-05
K962177 BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT C.R. Bard, Inc. DSP Class II 1996-09-04
K962115 CAMBRIDGE HEART HI-RES ECG ELECTRODE Cambridge Heart, Inc. DRX Class II 1996-08-29
K951128 MEDILOG STRESSLINK Oxford Medical, Inc. DPS Class II 1996-08-28
K962156 3304 PULSE OXIMETER Bci Intl., Inc. DQA Class II 1996-08-28
K960356 POSTERIOR ANNULOPLASTY BAND (MODEL 607) The Heart Valve Div. Medtronic Cardiovascular Surg KRH Class II 1996-08-27
K962154 CARBOMEDICS HANDLE Carbomedics, Inc. DTJ Class I 1996-08-27
K962036 MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD Medtronic Vascular DTB Class III 1996-08-22
K962174 BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) Intermedics, Inc. DTB Class III 1996-08-21
K960321 CARDIOCATH CATHETERIZATION LAB SYSTEM Prucka Engineering, Inc. DPS Class II 1996-08-21
K955546 PATIENT MONITOR MODEL 405P Ivy Biomedical Systems, Inc. DPS Class II 1996-08-16
K961936 MODEL 2188 CORONARY SINUS LEAD. Medtronic Vascular DTB Class III 1996-08-15
K955113 DINAMAP SELECT MULTI-PARAMETER SYSTEM Johnson & Johnson Medical, Inc. DPS Class II 1996-08-15
K961927 RMI HEMOCONCENTRACTOR TUBING SET Research Medical, Inc. DWF Class II 1996-08-13
K954205 THE AMPLATZ THROMBECTOMY DEVICE Microvena Corp. MCW Class II 1996-08-13
K961869 DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 Sorin Biomedical, Inc. DTM Class II 1996-08-12
K960445 INPUT TUOHY-BORST LOCKING DEVICE C.R. Bard, Inc. DYB Class II 1996-08-12
K955742 D. DEVICE II Yousef Daneshvar DXC Class II 1996-08-12
K961139 EAGLE PATIENT MONITOR MODEL 3000/3100 Marquette Electronics, Inc. DSI Class II 1996-08-09
K955270 TAPE & BANDAGE, ADHESIVE Robert R. Stevens DXC Class II 1996-08-08
K961288 BODYTRODE Marquette Electronics, Inc. DRX Class II 1996-08-08
K960625 SPREADABLE SHEATH INTRODUCER SET Neostar Medical Technologies, Inc. DYB Class II 1996-08-08
K962362 CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS Cordis Corp. DQY Class II 1996-08-08
K955525 FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70 Interventional Innovations Corp. KRA Class II 1996-08-08
K960544 CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM Nasiff Assoc., Inc. DRT Class II 1996-08-07

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