meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
1995-01-06

Clearances · page 122 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K940415 HORIZON 9000 WS Mennen Medical, Inc. DXG Class II 1995-01-06
K944858 BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS Baxter Edwards DSY Class II 1995-01-05
K944875 ANGIOMAT 3000, 6000, CT INJECTOR Lievel-Flarsheim Co. DXT Class II 1995-01-04
K935964 IDEAS OCCLUDER Ideas For Medicine, Inc. DXC Class II 1995-01-04
K935186 ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY Electrophysiology Systems, Inc. DQK Class II 1995-01-03
K943392 THERA-FLOW GRADIENT SEQUENTIAL PUMP Meds Systems, Inc. JOW Class II 1994-12-30
K945159 SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1994-12-30
K933156 DATEX AS/3 PATIENT MONITOR Datex Division Instrumentarium Corp. DPS Class II 1994-12-30
K943698 STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES Zoll Medical Corp MKJ Class III 1994-12-28
K942379 DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER Daig Corp. DRF Class II 1994-12-27
K944764 VTI DISPOSABLE PRESSURE DISPLAY SET Vascular Technology Incorporated DXS Class II 1994-12-27
K943287 ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP Ndm Acquisition Corp. JOW Class II 1994-12-27
K942613 SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR Koven Technology, Inc. DPW Class II 1994-12-23
K936091 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER Medtronic Bio-Medicus, Inc. DWA Class II 1994-12-23
K935922 360 SLX ADVISORY DEFIBRILLATOR Medical Research Laboratories, Inc. MKJ Class III 1994-12-22
K935985 DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION Deroyal Industries, Inc. DQO Class II 1994-12-21
K945465 CVD SMALL VESSEL BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. LIT Class II 1994-12-20
K944016 FOCUS BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. LIT Class II 1994-12-20
K942163 WINNER SELF-TAKING HOME BLOOD PRESSURE KIT Winmed Instruments Mfg. Corp. DXN Class II 1994-12-20
K943522 THE PROMPT GUIDWIRE Cordis Corp. DQX Class II 1994-12-19
K933391 ATRIUM'S HYBRID PTFE Atrium Medical Corp. DYF Class II 1994-12-15
K941162 HYPERGRAPH Dermed Diagnostics, Inc. DSB Class II 1994-12-15
K943256 CARDIAC OUTPUT OPTION 39 Medical Data Electronics DXG Class II 1994-12-15
K933846 ANGIOGRAPHY SYRINGE KITS Angiodynamics, Div. E-Z-Em, Inc. DXT Class II 1994-12-13
K941978 HIGH PRESSURE TUBING Abbott Laboratories DQO Class II 1994-12-13
K944460 DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD Datascope Corp. DSP Class II 1994-12-09
K945082 CYPRESS MEDICAL PRODUCTS STETHOSCOPE Cypress Medical Products, Ltd. LDE Class I 1994-12-08
K942453 GUIDE WIRE Boston Scientific Corp DQX Class II 1994-12-08
K942248 MINIATURIZED FINGER CLIP PULSE OXIMETER Nonin Medical, Inc. DQA Class II 1994-12-08
K941970 FAST-PATCH Physio-Control Corp. MKJ Class III 1994-12-07
K942565 ALTAIR-DISC RECORDER Burdick Corp. DQK Class II 1994-12-05
K935846 MODEL ACUITY CENTRAL STATION Protocol Systems, Inc. DSI Class II 1994-12-05
K942704 CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER Card Guard Scientific Survival , Ltd. DXH Class II 1994-12-05
K935371 R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD R2 Medical Systems DRX Class II 1994-12-02
K944337 VARIOUS STETHOSCOPES Rud Riester GmbH & CO KG LDE Class I 1994-11-30
K940302 ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM Arbo Medical, Inc. DSA Class II 1994-11-30
K943622 SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER Boston Scientific Scimed, Inc. DQY Class II 1994-11-30
K940079 ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 Arrow Intl., Inc. DYB Class II 1994-11-30
K943726 ACOUSTIC RECORDER Technology Applications Assoc., Inc. DQC Class I 1994-11-30
K942649 MINIMUS I; MINIMUS III, SANAPHON Rud Riester GmbH & CO KG DXN Class II 1994-11-29
K941490 BLOOD PRESSURE METER MODEL NO. BPM888 Integrated Display Technology, Ltd. DXN Class II 1994-11-29
K940189 COIL POSITIONER SET Cook, Inc. KRD Class II 1994-11-28
K942336 AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Integrated Display Technology, Ltd. DXN Class II 1994-11-28
K940322 ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE Arbo Medical, Inc. DSA Class II 1994-11-28
K943192 SCIMED CHOICE(TM) PTCA GUIDE WIRE Scimed Life Systems, Inc. DQO Class II 1994-11-22
K944655 ECG ELECTRODE Conmed Andover Medical, Inc. DRX Class II 1994-11-22
K935494 DANESHVAR'S DEVICE Y. Daneshvar DXC Class II 1994-11-22
K944726 1710 MONITORING ECG ELECTRODE Conmed Andover Medical, Inc. DRX Class II 1994-11-22
K934505 TRIGEL MULTIFUNCTION ELECTRODE Physiometrix, Inc. DRX Class II 1994-11-22
K935246 ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES Arbo Medical, Inc. DRX Class II 1994-11-16
K945035 OCL CONTOUR M-Pact Worldwide, LLC DXQ Class II 1994-11-15
K943739 SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical DQO Class II 1994-11-15
K941167 NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553) Spacelabs Medical, Inc. DXN Class II 1994-11-14
K944815 SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Scimed Life Systems, Inc. LIT Class II 1994-11-14
K932414 CONTINUOUS CARDIAC OUTPUT SYSTEM Abbott Laboratories DXG Class II 1994-11-14
K945214 MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE Graphic Controls Corp. DRX Class II 1994-11-10
K935839 GEMSCOM SERIES 5000, General Devices DRG Class II 1994-11-10
K935586 PRINCE Instromedix, Inc. DXH Class II 1994-11-08
K942400 BARD PERIPHERAL BALLOON DILATATION CATHETER C.R. Bard, Inc. LIT Class II 1994-11-07
K940703 MEDTRONIC MODEL 4558M Medtronic Vascular DTB Class III 1994-11-04
K942321 VARIOUSPATIENT MONITORING CABLE Merit Cables Incorporated DSA Class II 1994-11-04
K942635 MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1994-11-01
K940467 REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 Remington Medical, Inc. DTE Class II 1994-11-01
K935429 ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES Arbo Medical, Inc. DRX Class II 1994-11-01
K934644 K3 SYSTEM Astro-Med, Inc. DRT Class II 1994-11-01
K930599 BODY FAT ANALYZER MODEL TBF-105 Tanita Corp. of America DSB Class II 1994-11-01
K942094 CORDIS SAVVY PTA BALLOON CATHETER Cordis Corp. LIT Class II 1994-11-01
K924486 CARD GUARD, MODEL CG-9000 Card Guard Scientific Survival , Ltd. DXH Class II 1994-10-31
K945134 PORTABLE PATIENT MONITOR Hewlett-Packard Co. MHX Class II 1994-10-28
K945034 CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES Conmedcorp DSA Class II 1994-10-27
K925510 MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING Spacelabs Medical, Inc. DSI Class II 1994-10-27
K941492 PRESSURE RELIEF VALVE Circulatory Technology, Inc. MNJ Class II 1994-10-26
K944537 SCIMED TRIGUIDE GUIDE CATHETER Scimed Life Systems, Inc. DQY Class II 1994-10-21
K935394 MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION Marquette Electronics, Inc. DPS Class II 1994-10-20
K943278 TRACKER 2/TRACKER 3 HOLTER RECORDER Reynolds Medical , Ltd. DSH Class II 1994-10-20
K943817 MARQUETTE ADULT/NEONATAL WRAP SENSOR Marquette Electronics, Inc. DQA Class II 1994-10-18
K941706 OPTI-PLAST ANGIOPLASTY CATHETER Vas-Cath, Inc. LIT Class II 1994-10-18
K942269 MEDTRONIC EVEREST INFLATION DEVICE Medtronics Interventional Vascular MAV Class II 1994-10-18
K934016 POWERCHARGER Zoll Medical Corp DTE Class II 1994-10-18
K935597 FASGUIDE CATHETER Target Therapeutics DQY Class II 1994-10-18
K935349 LOCALMED INFUSION CATHETER Localmed, Inc. KRA Class II 1994-10-18
K942293 MS CLASSIQUE BALLOON CATHETER Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1994-10-18
K942871 PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM Colin Medical Instruments Corp. DXN Class II 1994-10-17
K943456 AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT Datex Division Instrumentarium Corp. DQA Class II 1994-10-17
K934684 PAM CARDIAC MONITOR Technology Transfer, Inc. DRT Class II 1994-10-17
K944760 DURA-Y OXYGEN TRANSDUCER, EAR CLIP Nellcor, Inc. DPZ Class II 1994-10-17
K944849 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE Conmed Andover Medical, Inc. DRX Class II 1994-10-17
K940982 ARTERIAL EMBOLIZATION DEVICE (KRD) Cook, Inc. KRD Class II 1994-10-14
K936232 BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER Boston Scientific Corp DSP Class II 1994-10-14
K943777 SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER Scimed Life Systems, Inc. DQY Class II 1994-10-13
K943783 7 FRENCH LARGE LUMEN TRIGUIDE-PLUS Scimed Life Systems, Inc. DQY Class II 1994-10-13
K941351 BURDICK PRO2 OXIMETER Burdick Corp. DQA Class II 1994-10-13
K943404 3301 PULSE OXIMETER Bci Intl., Inc. DQA Class II 1994-10-13
K944608 HP M1722A/B AND M1723A/B CODEMASTER Hewlett-Packard Co. DQA Class II 1994-10-04
K944667 LIFE PULSE TESUSCITATION TIMER Green Field Medical Sourcing, Inc. PMK Class I 1994-10-04
K931304 OHMEDA HAND HELD OXIMETER Ohmeda Medical DQA Class II 1994-09-29
K933014 LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI St. Jude Medical, Inc. KFM Class II 1994-09-28
K925143 MODEL 4800 ACCUPACE PACING SYSTEM ANALYER Pace Medical DTE Class II 1994-09-27
K930786 EPCOR Siemens Medical Solutions USA, Inc. DRW Class II 1994-09-26
K932141 CARDIAC CATHETERIZATION KIT Abbott Laboratories DQO Class II 1994-09-22

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