meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
39
Latest Decision
1989-11-01

Clearances · page 142 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K894940 DATASCOPE STEERING HANDLE Datascope Corp. DQX Class II 1989-11-01
K894970 WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. DTZ Class II 1989-11-01
K894239 NANOS Biotronik Cardiac Pacemakers DXY Class III 1989-11-01
K892641 BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES Bard Cardiosurgery Div DTZ Class II 1989-11-01
K892323 SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES Seismed Instruments, Inc. DSB Class II 1989-10-30
K884643 1100 VITAL SIGNS MONITOR Criticare Systems, Inc. DSI Class II 1989-10-30
K895098 BIOPSY FORCEPS Annex Medical, Inc. DWZ Class II 1989-10-30
K884126 E-RAM Reynolds Medical , Ltd. DSH Class II 1989-10-30
K895185 FIRST MEDIC MODEL 610P First Medical Devices Corp. LDD Class II 1989-10-27
K894892 HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM Koven and Assoc., Inc. DSB Class II 1989-10-27
K895113 COORDINATOR Cardiotronics, Inc. LDD Class II 1989-10-26
K894588 DEFIB/PACING PADS Conmedcorp DRO Class II 1989-10-26
K894945 NON-INVASIVE BLOOD PRESSURE MODULE Marquette Electronics, Inc. DXN Class II 1989-10-26
K893643 NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER Novametrix Medical Systems, Inc. DQA Class II 1989-10-26
K894607 PAQ10 PAPER CHART RECORDER Protocol Systems, Inc. DSF Class I 1989-10-26
K894991 ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. Labeltape Meditect, Inc. DRX Class II 1989-10-26
K894240 NEOS 02 Biotronik Cardiac Pacemakers DXY Class III 1989-10-26
K894630 SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR Shiley, Inc. DTZ Class II 1989-10-20
K894721 TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE The Traumafuse Co. DWE Class II 1989-10-20
K894632 MODEL SSH-140A ULTRASOUND IMAGING SYSTEM Toshiba America Medical Systems, In.C DXK Class II 1989-10-19
K894033 DISPOSABLE CATHETER PRESSURE TRANSDUCER Deseret Medical, Inc. DXO Class II 1989-10-17
K894684 PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT Pioneering Technologies, Inc. DWF Class II 1989-10-17
K894633 CORDIS STEERABLE COATED GUIDEWIRE Cordis Corp. DQX Class II 1989-10-17
K894494 LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD Biotronik, GmbH & Co. DXY Class III 1989-10-17
K890875 CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 Ppg Industries, Inc. DPS Class II 1989-10-17
K894496 OLYMPUS VALVULOTOME W/FIXED TIP Olympus Corp. DWX Class II 1989-10-12
K894858 CARE 5000 SYSTEM Care Systems, Inc. DSI Class II 1989-10-12
K894976 ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP. Medtronic Vascular DTD Class II 1989-10-12
K894681 REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER Shiley, Inc. DXE Class II 1989-10-12
K893990 P POLYMER Pace West LDD Class II 1989-10-12
K895729 R2 PACE PAD, MODEL 480 Darox Corp. DRO Class II 1989-10-12
K893830 HEMO-ALERT Koregon Enterprise, Inc. DQO Class II 1989-10-12
K894318 DATASCOPE INTERLOCK GUIDE WIRE EXTENSION Datascope Corp. DQX Class II 1989-10-12
K894732 VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION) Medtronic Vascular DSY Class II 1989-10-12
K895728 R2 PACE ADAPTOR CABLE, MODEL 196 Darox Corp. DRO Class II 1989-10-12
K895032 ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES Zmi Corp. LDD Class II 1989-10-12
K894462 CARE DISP. DIAG. ELECTRODES, SILVER/SILVER Labeltape Meditect, Inc. DRX Class II 1989-10-12
K891786 PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) Pioneering Technologies, Inc. DWP Class II 1989-10-12
K894747 PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. Endosonics Corp. DXO Class II 1989-10-12
K894540 TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000 Physio-Control Corp. DXH Class II 1989-10-12
K891576 FEM-FLEX FEMORAL ACCESS CANNULATION SET Research Medical, Inc. DWF Class II 1989-10-12
K894286 PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER Ppg Industries, Inc. DXO Class II 1989-10-12
K885085 ERGOMED 840/ERGOMED 840L Burdick Corp. DRT Class II 1989-10-03
K894799 CARDIOBEEPER MEMORY MONITOR CB 600 SERIES Survival Technology, Inc. DXH Class II 1989-10-03
K894920 SELECTRODE S & W Medico Teknik DRX Class II 1989-10-03
K893094 HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM Heartware Intl. Corp. JOQ Class II 1989-10-02
K894693 AP-851PA NIBP MODULE Nihon Kohden America, Inc. DXN Class II 1989-10-02
K894699 TYPE 9140 (SYSTEM ATHENA) S & W Medico Teknik DRT Class II 1989-10-02
K894445 MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE Mallinckroot, Inc. DYB Class II 1989-10-02
K894340 PCI MODEL 2041-A TELEMETRY MONITOR Accucore, Inc. DXH Class II 1989-10-02
K893405 MODEL DS-504 DYNASCOPE PATIENT MONITOR Fukuda Denshi USA, Inc. DRT Class II 1989-10-02
K894460 SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA Siemens Medical Electronics DSI Class II 1989-10-02
K894700 TYPE PDU/CDU 9040 (SYSTEM ATHENA) S & W Medico Teknik DRT Class II 1989-10-02
K894692 BEDSIDE MONITORS, BSM-8301A, BSM-8302A Nihon Kohden America, Inc. DSI Class II 1989-10-02
K894157 OBTURATOR Argon Medical Corp. DYB Class II 1989-09-28
K894105 TARGET THERAPEUTICS TRACKER LF CATHETER Target Therapeutics DQY Class II 1989-09-28
K895110 MAESTRO PACEMAKER TEST MAGNET Cardiac Control Systems, Inc. DTG Class I 1989-09-26
K894285 DMI PC HOLTER SCANNER Diagnostic Medical Instruments DSI Class II 1989-09-26
K893626 FLEXMEDICS GUIDEWIRE Flexmedics DQX Class II 1989-09-26
K893471 MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING Medtronic Vascular DXH Class II 1989-09-26
K892530 CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH Arrow Intl., Inc. DYG Class II 1989-09-26
K894277 M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME Hewlett-Packard Co. DXH Class II 1989-09-26
K894942 SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER Boston Scientific Corp DSP Class II 1989-09-26
K894343 DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO Daig Corp. DYB Class II 1989-09-26
K892120 ESCORT PULSE OXIMETRY OPTION Medical Data Electronics DQA Class II 1989-09-26
K895495 ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS Medtronic Vascular DXY Class III 1989-09-26
K894131 DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 Thermedics, Inc. DQY Class II 1989-09-26
K890597 EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS D-R Medical Systems, Inc. DSY Class II 1989-09-26
K894065 OPUS MODEL 4001 Ela Medical, Inc. DXY Class III 1989-09-26
K893435 SILICONE FLOW-DIRECTED THERMODILUTION CATHETER Cathlab Corp. DYG Class II 1989-09-26
K895425 MINIMON 7137B PATIENT MONITOR Kontron Instruments, Inc. DQA Class II 1989-09-26
K894255 ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP St. Jude Medical, Inc. KFM Class II 1989-09-26
K891928 HOLTAIN BODY COMPOSITION ANALYSER Seritex, Inc. DSB Class II 1989-09-22
K894103 SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II Scimed Life Systems, Inc. DTZ Class II 1989-09-21
K892799 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. DSP Class II 1989-09-20
K893459 PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE) Medtronic Vascular DSY Class II 1989-09-20
K894981 MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE Medtronic Vascular DSA Class II 1989-09-20
K892797 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. DSP Class II 1989-09-20
K894267 OPUS MODELS 4033 AND 4034 Ela Medical, Inc. DXY Class III 1989-09-20
K892798 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. DSP Class II 1989-09-20
K894243 RMI ARTERIAL PERFUSION CANNULA Research Medical, Inc. DQR Class II 1989-09-19
K890766 CATHETER INTRODUCER SHEATH Applied Vascular Devices, Inc. DYB Class II 1989-09-18
K894500 DAIG ELECTROPHYSIOLOGY CATHETER Daig Corp. DRF Class II 1989-09-18
K894735 ASC-952 PHYSIOLOGICAL AMPLIFIER Astro-Med, Inc. DRR Class II 1989-09-18
K894919 NR5000 E.C.G. AND PULSE OXIMETER MONITOR Nirad , Ltd. DRT Class II 1989-09-18
K891021 TRI-LUMEN INTRA VASCULAR BALLOON CATHETER Ideal Medical, Inc. DXE Class II 1989-09-18
K894679 ELECTROTRACE DISP. RESTING EKG ELECTRODES Jason Marketing Co. DRX Class II 1989-09-13
K892878 KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 Kontron Instruments, Inc. DSP Class II 1989-09-13
K891122 DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. Big Valley Medical LDD Class II 1989-09-13
K893867 CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE Spacelabs, Inc. DQA Class II 1989-09-13
K894738 MODEL 6888 LEAD TUNNELER Cardiac Pacemakers, Inc. DWS Class I 1989-09-13
K890959 GUIDEWIRE Guidewire Technologies, Inc. DQX Class II 1989-09-12
K891231 OPTIMA MPT AND SPT PACEMAKERS Telectronics, Inc. DXY Class III 1989-09-12
K894682 USCI UNCOATED GUIDING CATHETERS C.R. Bard, Inc. DQY Class II 1989-09-12
K894330 DAIG VESSEL DILATOR Daig Corp. DRE Class II 1989-09-12
K893836 EPLAB (ELECTROCARDIOGRAPHIC MONITOR) Quinton Electrophysiology Corp. DSH Class II 1989-09-08
K894431 MODIFIED LABELING TO PERMANENT LEAD INTRODUCER Daig Corp. DYB Class II 1989-09-06
K894648 ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO Arbo Medical, Inc. DRX Class II 1989-09-05
K893474 BARD CATH LAB THERMODILUTION CATHETER C.R. Bard, Inc. DYG Class II 1989-09-05
K894562 ARBO H79P DISPOSABLE MONITORING ELECTRODES Arbo Medical, Inc. DRX Class II 1989-09-05

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