meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1990-04-04

Clearances · page 140 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K901032 PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA Accucore, Inc. DPS Class II 1990-04-04
K895801 MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM Marquette Electronics, Inc. DRT Class II 1990-04-04
K895806 ELATEC HOLTER ANALYZER Ela Medical, Inc. DSI Class II 1990-04-04
K900866 OXIMAX 700 Pace Tech, Inc. DQA Class II 1990-04-04
K900672 PREBYPASS FILTER, CAT. NO. FPB-5 American Omni Medical, Inc. KRJ Class II 1990-04-03
K900700 SMU 611 UNIVERSALMONITOR Ppg Industries, Inc. DPS Class II 1990-04-03
K900002 DOPPLER OPTION FOR PLATINUM Philips Medical Systems North America, Inc. DXK Class II 1990-04-02
K896308 CORDIS SHUTTLE CATHETER Cordis Corp. DQO Class II 1990-03-28
K900601 SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY 3M Company KFM Class II 1990-03-28
K900130 MODIFIED SEISMOCARDIOGRAPH Seismed Instruments, Inc. DSB Class II 1990-03-28
K900843 OXIMAX 100 Pace Tech, Inc. DQA Class II 1990-03-28
K900339 HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES Shiley, Inc. DTS Class II 1990-03-28
K894784 MODIFIED SHILEY FEMORAL VENOUS CANNULA Shiley, Inc. DQR Class II 1990-03-28
K897137 RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING Research Medical, Inc. DTL Class II 1990-03-27
K897196 ADVANCE STOPCOCKS ADVANCE MANIFOLDS Advance Medical Designs, Inc. DTL Class II 1990-03-27
K895588 PORTABLE AIR PLETHYSMOGRAPH Life Sciences Manufacturing, Inc. DSB Class II 1990-03-27
K895326 EUB-165 Hitachi Medical Corp. of America DXK Class II 1990-03-22
K896967 HTS 820 CARDIAC MONITOR Life Sensing Instrument Company, Inc. DSI Class II 1990-03-19
K895535 PACEVIEW Micromedical KRE Class II 1990-03-19
K893557 ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING) Medical Monitors, Inc. DQD Class II 1990-03-19
K897197 ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. Advance Medical Designs, Inc. DTL Class II 1990-03-19
K900519 CLASSIC ECG/STIMULATING NO. 1700 SERIES Classic Medical Products, Inc. DRX Class II 1990-03-19
K900379 HYCULT DIAMOND CORONARY BYPASS KNIFE St. Jude Medical, Inc. DWS Class I 1990-03-19
K895534 BIOLOG Micromedical DRT Class II 1990-03-19
K897022 PICSO CANNULA, CATALOG CODE 94315 Dlp, Inc. DWF Class II 1990-03-16
K897051 MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH Cathlab Corp. DQO Class II 1990-03-16
K897041 HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS C.R. Bard, Inc. DYB Class II 1990-03-16
K897039 SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM) 3M Company DTR Class II 1990-03-16
K895017 SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH Sorba Medical Systems, Inc. DXG Class II 1990-03-14
K900461 OPUS MODEL 4021, VVI, 5MM UNIPOLAR Ela Medical, Inc. DXY Class III 1990-03-14
K897184 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS Cathlab Corp. DXE Class II 1990-03-14
K900452 QUATTRO CATHETER Ep Technologies, Inc. DRF Class II 1990-03-14
K897116 OPTIMA MPT MODEL 5281E AND MODEL 5282E Telectronics Pacing Systems, Inc. DXY Class III 1990-03-14
K896958 ESCORT NON-INVASIVE BLOOD PRESSURE OPTION Medical Data Electronics DXN Class II 1990-03-13
K895972 CURITY(R) PERCUTANEOUS CATHETERS Kendall Healthcare Products Co. Div.Of Tyco Health DQY Class II 1990-03-13
K895547 GRANDCOR/CARDIOLINE ECT STRESS TESTING Grandcor Medical Systems DSI Class II 1990-03-13
K900553 CONSTANT CURRENT STIMULATOR MODEL 022101 Ep Technologies, Inc. JOQ Class II 1990-03-13
K897004 NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM Advanced Technology Laboratories, Inc. DXG Class II 1990-03-13
K896190 CARDIOCAP(TM) CMX-104 MONITOR Datex Division Instrumentarium Corp. DPS Class II 1990-03-08
K894250 LE PTA CATHETER Baxter Healthcare Corp LIT Class II 1990-03-07
K890895 IMPLANTABLE ADAPTOR 033-380 Telectronics, Inc. DTD Class II 1990-03-06
K884235 COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT Burron Medical, Inc. DRS Class II 1990-03-06
K897082 SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR Schneider Intl., Ltd. DQY Class II 1990-03-06
K895719 TELEREHAB SYSTEM FOR CARDIAC REHABILITATION Scottcare Corp. DXH Class II 1990-03-06
K896986 BLOOD PRESSURE CUFF Latex Medical Devices, Inc. DXQ Class II 1990-03-06
K894563 OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F Omron Electronics, Inc. DXN Class II 1990-03-06
K897080 CARDIOCAP(TM) CT-104 MONITOR Datex Division Instrumentarium Corp. DRT Class II 1990-03-06
K896403 MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM Intensive Technology, Inc. LIT Class II 1990-03-06
K900605 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 Possis Medical, Inc. DTD Class II 1990-03-06
K895356 UNIVOX-IC Baxter Healthcare Corp DTN Class II 1990-03-06
K896920 SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER Boston Scientific Corp DSP Class II 1990-03-06
K896313 MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. Medtronic Vascular DTB Class III 1990-03-06
K896849 ACS INDEFLATOR XX Advanced Cardiovascular Systems, Inc. MAV Class II 1990-02-28
K893221 MODEL 8500 HAND HELD PULSE OXIMETER Nonin Medical, Inc. DQA Class II 1990-02-28
K896039 KING OF HEARTS 1200 MONITOR Instromedix, Inc. DXH Class II 1990-02-28
K895511 CATHETER BALLOON DILATOR PRESSURE GAUGE Argon Medical Corp. MAV Class II 1990-02-28
K895179 ACCESSOR PERIPHERAL DILATING GUIDE WIRE Peripheral Systems Group LIT Class II 1990-02-28
K896741 SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH. Schneider Intl., Ltd. DQO Class II 1990-02-28
K894826 UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF Bentley Laboratories, Inc. DTZ Class II 1990-02-28
K890182 PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV Aesculap Instruments Corp. DSY Class II 1990-02-28
K896978 CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE Medtronic Vascular DTZ Class II 1990-02-28
K893711 DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR Shiley, Inc. DTN Class II 1990-02-28
K885046 INSITUCAT VALVE STRIPPER Aesculap Instruments Corp. DWQ Class II 1990-02-28
K896777 RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE Research Medical, Inc. DWF Class II 1990-02-27
K896778 RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE Research Medical, Inc. DWF Class II 1990-02-27
K896771 EKG, ECG KENZ, ECG 302 Cambridge Medical Instruments, Inc. DSI Class II 1990-02-26
K896772 EKG, ECG KENZ, ECG 303 Cambridge Medical Instruments, Inc. DPS Class II 1990-02-26
K895688 NOBLES-LAI ENGINEERING INFUSION PUMP Nobles-Lai Engineering, Inc. DQI Class II 1990-02-26
K897026 CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO. Canyon Medical Products DWF Class II 1990-02-26
K896005 SMALL CATHETER INFLATOR Allied Systems Co. MAV Class II 1990-02-26
K895044 DUAL GUIDE INTRODUCER CATHETER Cook, Inc. DYB Class II 1990-02-26
K895379 LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) Physio-Control Corp. LDD Class II 1990-02-26
K897152 CRAGG CONVERTIBLE WIRE Boston Scientific Corp DQX Class II 1990-02-22
K895987 KELLER PULSE OXIMETER - KMS 850 Keller Medical Specialties Products, Inc. DQA Class II 1990-02-22
K895971 TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING Telectronics Pacing Systems, Inc. DTD Class II 1990-02-22
K896613 FLAT VASCULAR PROBE Imex Medical Systems, Inc. DPW Class II 1990-02-16
K896543 ULTRAMARK 7 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. DXK Class II 1990-02-15
K896636 RMI ANTEPLEGIA CANNULA Research Medical, Inc. DWF Class II 1990-02-15
K896671 SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461 3M Company DTZ Class II 1990-02-14
K895793 MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION Del Mar Avionics DSH Class II 1990-02-13
K896515 LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 Tsi, Inc. DPW Class II 1990-02-13
K892664 CARDIOPULMONARY SUPPORT (CPS) SYSTEM Bard Cardiosurgery Div DTZ Class II 1990-02-13
K896597 THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. Boston Scientific Corp DSP Class II 1990-02-12
K895136 PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA Medtronic Vascular DTB Class III 1990-02-08
K896466 SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME Baxter Healthcare Corp DYG Class II 1990-02-08
K894543 MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER Del Mar Avionics DSI Class II 1990-02-08
K896435 HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM Hewlett-Packard Co. DPT Class II 1990-02-07
K894956 CIRCAMED HOLTER VERSION 4 Circadian, Inc. DPS Class II 1990-02-05
K896974 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 Daily Medical Products, Inc. DWC Class II 1990-02-05
K897067 MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES Telectronics Pacing Systems, Inc. DTB Class III 1990-02-05
K896430 PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI Datascope Corp. DSP Class II 1990-02-05
K896972 CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 Daily Medical Products, Inc. DWC Class II 1990-02-05
K896975 CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 Daily Medical Products, Inc. DWC Class II 1990-02-05
K896971 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 Daily Medical Products, Inc. DWC Class II 1990-02-05
K896973 CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 Daily Medical Products, Inc. DWC Class II 1990-02-05
K896393 CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 Daily Medical, Inc. DWC Class II 1990-02-02
K896379 ACS GOLD SERIES ELASTINITE GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1990-02-02
K897063 FUKUDA DENSHI MODEL DS-3300 ETR Fukuda Denshi USA, Inc. DSI Class II 1990-02-01
K896633 AUTO-CUFF(TM) U.S. Medical Corp. DXN Class II 1990-02-01
K895074 ANGIOSCOPY PUMP Baxter Healthcare Corp DQI Class II 1990-01-31

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