meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1992-07-24

Clearances · page 130 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920135 MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE Medroyal, Inc. DXT Class II 1992-07-24
K922302 JAGWIRE(TM) RECANALIZATION GUIDEWIRE Boston Scientific Corp DQX Class II 1992-07-24
K922410 SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL Scimed Life Systems, Inc. DQX Class II 1992-07-23
K921997 CUFF-M Lorin Medical, Inc. DXQ Class II 1992-07-23
K920844 PIM 1.0 LASER DOPPLER PERFUSION IMAGER Lisca Development AB DPW Class II 1992-07-21
K921856 TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. Schneider Intl., Ltd. LIT Class II 1992-07-21
K921879 CBIS CATHETER PULL-BACK DEVICE Cardiovascular Imaging Systems, Inc. DQO Class II 1992-07-16
K920379 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX Novametrix Medical Systems, Inc. DQA Class II 1992-07-15
K914538 UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER Innovative Medical Products, Inc. DQA Class II 1992-07-14
K913844 ACCUTRACKER DX Suntech Medical Instruments, Inc. DXN Class II 1992-07-14
K920177 VERSA-VIAL Bioteque America, Inc. DQF Class II 1992-07-13
K920020 CARDIO-CARD ECG MANAGEMENT SYSTEM Nasiff Assoc., Inc. DPS Class II 1992-07-09
K915183 SARNS 8000 MODULAR PERFUSION SYSTEM 3M Health Care, Sarns DTQ Class II 1992-07-08
K920765 EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200 Electronic Monitoring Devices, Inc. DXH Class II 1992-07-07
K920990 LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR) Raco Products Co. LDD Class II 1992-07-06
K922412 ECG MODULATOR Maguire Ent., Inc. DXH Class II 1992-07-06
K915351 SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER Medtronics Interventional Vascular DQO Class II 1992-06-29
K915328 GEL-TAC Katecho, Inc. DRO Class II 1992-06-29
K915773 P-300 CAPNOGRAPH AND PULSE OXIMETER Pryon Corp. DQA Class II 1992-06-24
K912183 TYPE 9050/NEO S & W Medico Teknik DPS Class II 1992-06-23
K921562 JOBST EXTREMITY PUMP SYSTEM 7500 Jobst Institute, Inc. JOW Class II 1992-06-22
K911065 ARROW QUADPOLAR MAPPING/PACING CATHETER Arrow Intl., Inc. DRF Class II 1992-06-18
K920432 BAIR HUGGER CUB BLANKET- SHORT MODEL 536 Augustine Medical, Inc. DWJ Class II 1992-06-18
K921943 SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL Schneider Intl., Ltd. LIT Class II 1992-06-17
K922227 MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE Cardiotronics, Inc. LDD Class II 1992-06-11
K922172 MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) Cardiotronics, Inc. LDD Class II 1992-06-11
K922173 MODEL # 830 ST ADULT STIMULATION PADS (STERILE) Cardiotronics, Inc. LDD Class II 1992-06-11
K915078 MORSE HEMOSTATIC CATHETER INTRODUCER SET North American Instrument Corp. DYB Class II 1992-06-10
K915723 .10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1992-06-09
K914194 SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1992-06-09
K913267 R-GROUP INTL. ONE WALL PUNCTURE NEEDLE R-Group Intl. DRC Class II 1992-06-05
K915895 STEALTH DILATION CATHETER SYSTEM (MODIFIED) Target Therapeutics LIT Class II 1992-06-04
K914299 CARDIAC CATHERIZATION KIT Abbott Laboratories DQO Class II 1992-06-03
K920779 FAST-CATH HEMOSTASIS INTRODUCER Daig Corp. DYB Class II 1992-06-03
K915625 INTRODUCER CATHETER Interventional Therapeutics Corp. DYB Class II 1992-06-03
K920998 GORE TUNNELER, MODIFICATION W. L. Gore & Associates, Inc. DYB Class II 1992-06-03
K910077 CRIT-SCAN Noninvasive Medical Technology Corp. DQA Class II 1992-06-02
K920501 SILCLAMPS DEGANIA SILICONE Puritas Health Care, Inc. DXC Class II 1992-06-02
K914092 BSM-2100A CONFIGURED PATIENT MONITOR Nihon Kohden America, Inc. DSI Class II 1992-05-28
K921606 MODEL #125 CHILD STIMULATION PADS Cardiotronics, Inc. LDD Class II 1992-05-26
K921579 BR-50-J DISPOSABLE ECG ELECTRODE Medicotest, Inc. DRX Class II 1992-05-26
K921124 MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS Medtronic Vascular DTB Class III 1992-05-22
K921550 LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP St. Jude Medical, Inc. KFM Class II 1992-05-21
K914984 E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION E-Z-Em, Inc. DQY Class II 1992-05-20
K914986 GUIDE WIRES, MODIFICATION E-Z-Em, Inc. DQX Class II 1992-05-20
K914987 HIGH PRESSURE CONNECTING SETS, MODIFICATION E-Z-Em, Inc. DTL Class II 1992-05-20
K914754 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D Medtronic Bio-Medicus, Inc. DWA Class II 1992-05-20
K913209 ACCESSORY TO GENESIS III (GCFM) Biosound, Inc. DXK Class II 1992-05-15
K914955 K-DEFIB/PACE ELECTRODE Katecho, Inc. DRO Class II 1992-05-14
K921331 CAMBRIDGE PC/GXT STRESS TEST SYSTEM Health Watch, Inc. DPS Class II 1992-05-11
K914577 RHYTHMSCAN PRECISION 6000 Precision Health Care Systems, Inc. DQK Class II 1992-05-08
K920547 ULTRA-THIN Boston Scientific Corp LIT Class II 1992-05-06
K914620 HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION Vitalog Monitoring,Inc. DQA Class II 1992-05-01
K914856 VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM) Cook, Inc. DQY Class II 1992-05-01
K913117 ZB-860PA MULTIPARAMETER TRANSMITTER Nihon Kohden America, Inc. DSI Class II 1992-04-29
K902977 K3 COMPUTER SYSTEMS Donald L. King M.D. DPT Class II 1992-04-28
K915153 ESCORT-LINK ARRHYTHMIA OPTION 23L Medical Data Electronics DSI Class II 1992-04-27
K913803 INTRALUMINAL ARTERY STRIPPER Omni-Tract Surgical, Div. Minn. Scientific, Inc. DWX Class II 1992-04-24
K920331 RIGHT ATRIAL CATHETER KITS Akcess Medical Products, Inc. DQY Class II 1992-04-22
K915280 FEMOSTOP Radi Medical Systems AB DXC Class II 1992-04-22
K914382 LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM Progressive Dynamics, Inc. DWJ Class II 1992-04-21
K920104 IDENTI LOOPS DEGANIA SILICONE Puritas Health Care, Inc. DSS Class II 1992-04-20
K915775 MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN Millar Instruments, Inc. DXO Class II 1992-04-20
K914786 TARGET THERAPEUTICS COILS Target Therapeutics KRD Class II 1992-04-20
K915498 CORDIS ANGIOGRAPHIC DOPPLER CATHER Cordis Corp. DQO Class II 1992-04-17
K920327 DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER Daig Corp. DYB Class II 1992-04-16
K920676 RMI SOFCLAMP Research Medical, Inc. DSS Class II 1992-04-15
K914461 A-V IMPULSE SYSTEM Novamedix , Ltd. JOW Class II 1992-04-15
K915632 PACEART CPTS-86/12 Paceart, Inc. KRE Class II 1992-04-14
K920867 EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG Electro Medical Equipment Co., Inc. DRX Class II 1992-04-10
K912816 PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE S & W Medico Teknik DSK Class II 1992-04-10
K920408 DESERET GUIDEWIRE INTRODUCER III Bd Becton Dickinson Vacutainer Systems Preanalytic DQO Class II 1992-04-07
K920407 DESERET GUIDEWIRE INTRODUCER II Bd Becton Dickinson Vacutainer Systems Preanalytic DQO Class II 1992-04-07
K920572 UNISCAN 24 ECG ROCORDER Uniscan , Ltd. DSH Class II 1992-04-06
K914383 LIFE-AIR 1000 PATIENT WARMING COVERS Progressive Dynamics, Inc. DWJ Class II 1992-03-30
K921068 GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 Datrix DSH Class II 1992-03-30
K914206 ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST Kardiosis Ltd. Co. DPS Class II 1992-03-30
K920289 CORDIS BIPAL 7 BIOPSY FORCEPS Cordis Corp. DWZ Class II 1992-03-30
K920265 BAIR HUGGER PATIENT WARMING SYSTEM Augustine Medical, Inc. DWJ Class II 1992-03-27
K913595 DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM Koven and Assoc., Inc. DXN Class II 1992-03-27
K915624 MODIFIED BIOLOG Micromedical Industries, Ltd. DRT Class II 1992-03-27
K915627 PACEVIEW Micromedical Industries, Ltd. KRB Class II 1992-03-27
K915521 TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED Target Therapeutics DQY Class II 1992-03-23
K910929 OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V. Ohmeda Medical DSI Class II 1992-03-19
K920251 USCI HEMAQUET XT INTRODUCER C.R. Bard, Inc. DYB Class II 1992-03-18
K920530 INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG Intermedics, Inc. DXY Class III 1992-03-17
K920364 ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS Biosound, Inc. DPS Class II 1992-03-17
K920157 SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER Schneider Intl., Ltd. DXY Class III 1992-03-16
K914880 DUAL BALLOON EMBOLECTOMY CATHETER Ideal Medical, Inc. DXE Class II 1992-03-16
K913847 SYSTEM 90 AND SYSTEM 90T Datascope Corp. DSP Class II 1992-03-11
K912629 DATASCOPE SYSTEM 95 Datascope Corp. DSP Class II 1992-03-11
K915640 VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER Arrhythmia Technologies, Inc. DRF Class II 1992-03-09
K920099 GYMMAN Lumiscope Co., Inc. DRT Class II 1992-03-09
K915563 DIAGNOSTIC EP CATHETER Arrhythmia Technologies, Inc. DRF Class II 1992-03-09
K911645 NGM NIBP MODULE Datex Division Instrumentarium Corp. DXN Class II 1992-03-04
K914889 GEMSCOM SERIES 3000 General Devices DRG Class II 1992-03-04
K915193 SARNS RETROGRADE CANNULA 3M Health Care, Sarns DWF Class II 1992-03-04
K914278 DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN Daig Corp. DRF Class II 1992-03-04
K914385 OPTICAL VALVULOTOME Intramed Laboratories, Inc. MGZ Class II 1992-03-02
K915496 DESERET GUIDEWIRE INTRODUCER Bd Becton Dickinson Vacutainer Systems Preanalytic DQX Class II 1992-02-27

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