meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
1984-01-30

Clearances · page 169 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K833583 VERIFORM II American Medical Systems, Inc. DXN Class II 1984-01-30
K833753 AC ADAPTERS FOR BLOOD PRESSURE METERS Philips Park DXN Class II 1984-01-30
K833584 VITAL SIGNS MONITOR 3 Physio-Control Corp. DPS Class II 1984-01-30
K833421 PROGRAMMABLE STIMULATOR 2352 Medtronic Vascular JOQ Class II 1984-01-30
K834041 CARDIOTOMY RESERVOIR SC3500F Scimed Life Systems, Inc. DTP Class II 1984-01-30
K832876 LIFEPAK 7P Physio-Control Corp. DRO Class II 1984-01-30
K833695 ADULT MONITORING ELECTOR@@RODE 9431-300 Marquette Electronics, Inc. DRX Class II 1984-01-27
K831763 MAX I Trade Max, Inc. DQD Class II 1984-01-27
K834220 HYBRID PERIPHERAL DILATION CATHETER American Edwards Laboratories LIT Class II 1984-01-27
K834352 ADULT VENT CATHETER Dlp, Inc. DRA Class II 1984-01-27
K833619 CONDUCTANCE METER Circadian, Inc. KRC Class II 1984-01-27
K833902 VASOSCAN Sonicaid, Inc. JOP Class II 1984-01-27
K833078 HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 Cordis Corp. DTZ Class II 1984-01-27
K833552 TREND PROCESSOR OPTION FOR #515 NEONAT Ge Medical Systems Information Technologies DRT Class II 1984-01-27
K832644 ALPHA CARDIAC OUTPUT CARDULE #1899 Spacelabs, Inc. DXG Class II 1984-01-27
K832764 ALPHA NON-INVASIVE BP CARDULE Spacelabs, Inc. DXN Class II 1984-01-27
K832354 HOLTA-MED INFORMER PLAYBACK Holta-Med DSI Class II 1984-01-27
K833155 RAYDEN MEDICAL MINI PULSE VOLUME RECORD Burditt & Calkins-Siemens-Elema DSB Class II 1984-01-26
K833547 ROTARY VASCULAR KNIFE Formedco, Inc. DWS Class I 1984-01-26
K832888 ECG INTERFERENCE FILTER TF-03 La Jolla Technology, Inc. DPS Class II 1984-01-18
K834107 ANGIOPLASTY INFLATION DEVICE & CARTR Cordis Corp. DXT Class II 1984-01-13
K833574 PERCUTANEOUS SHEATH INTRODUCER TRAYS Intermed, Inc. DQX Class II 1984-01-11
K833751 PORTA PULSE III #D320 Medical Research Laboratories, Inc. LDD Class II 1984-01-11
K833573 CENTRAL VEIN CATH. TRAY CC-20-1420 Intermed, Inc. DQY Class II 1984-01-11
K832817 TELEMETRY SYS SERIES 7700 ECG Marquette Electronics, Inc. DRG Class II 1984-01-10
K834037 HEPARIN COATED BALLOON THERMODILU Nova Medical Specialties DYG Class II 1984-01-10
K833395 SENTINEL SYSTEMS Quantitative Medicine, Inc. DXG Class II 1984-01-10
K833716 LP200 & HP800 SERIES VASCULAR PROSTH Intervascular, Inc. DSY Class II 1984-01-10
K833825 MULTI-LUMEN INTRAVENOUS INFUSION CATH Medical Parameters, Inc. DQY Class II 1984-01-10
K834036 HEPARIN COATED BALLOON THERMODILU Nova Medical Specialties DYG Class II 1984-01-10
K832907 INVASIVE MONITORING KITS American Pharmaseal Div. Ahsc DRS Class II 1984-01-10
K833162 AMBULATORY MONITORING DEVICE Oxford Medilog, Inc. DSI Class II 1984-01-10
K831516 GORE-TEX SURGICAL MEMBRANE W. L. Gore & Associates, Inc. DXZ Class II 1984-01-06
K832679 NON-INVASIVE CLINICAL VASCULAR LAB Life Sciences Manufacturing, Inc. DQC Class I 1984-01-03
K833670 BOS-CM40,50 HOLDER & RESERVOIR BAG American Bentley DTZ Class II 1984-01-03
K834039 INFANT VENT CATHETER 12001 W/SIDE VENT Dlp, Inc. DWF Class II 1984-01-03
K834025 SARNS CARDIOPLEGIA CANNULA Y 3M Health Care, Sarns DWF Class II 1984-01-03
K833826 BTI BIOX III OXIMETER CRITICAL CAREUNI Biox Technology, Inc. DQA Class II 1983-12-30
K831507 LOW TRAUMA ARTERIAL FILTER H-640 C.R. Bard, Inc. DTM Class II 1983-12-29
K833433 PHYSIO-PROBE-HIGH PERMEABILITY CATH. Research Industries Corp. DQY Class II 1983-12-29
K833662 CARDIOPLEGIA SYSTEM CCS-XXX SERIES Gish Biomedical, Inc. DTR Class II 1983-12-29
K833518 BLOOD OXYGENATOR HEAT EXHANGER COATING American Bentley DTZ Class II 1983-12-29
K832802 USE OF TWEEN 80 AS A WETTING AGENT ON American Bentley DTN Class II 1983-12-29
K833477 INTERSEPT 40 MICRON FILTER Extracorporeal Medical Specialities, Inc. DTM Class II 1983-12-27
K833303 DUOFLO 6F Argon Medical Corp. DQY Class II 1983-12-27
K833879 CARDIOPULMONARY RESUSCITATOR Michigan Instruments, Inc. DRM Class II 1983-12-27
K832607 OPEN END SPRING GUIDE C.R. Bard, Inc. DQX Class II 1983-12-27
K832671 CARDIOTOMY RESERVOIR-FILTER 050-108-050 Cobe Laboratories, Inc. DTN Class II 1983-12-27
K833476 INTERSEPT 40 MICRON FILTER W/TUBING Extracorporeal Medical Specialities, Inc. DTM Class II 1983-12-27
K833616 OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1983-12-26
K833021 PERI-GUARD PERICARDIAL PATCH-HERNIA Genetic DXZ Class II 1983-12-26
K832724 ACTIMETER UB-103 Copal, Inc. DRT Class II 1983-12-22
K833248 LOW PROFILE STEERABLE-INTRAOPERATIVE Advanced Cardiovascular Systems, Inc. LIT Class II 1983-12-22
K832754 MONITORING SYSTEM AS100-AS115 RECORD Air-Shields, Inc. DSF Class I 1983-12-22
K830338 NARCOTRACE 80 Narco Scientific DXN Class II 1983-12-22
K832877 PRE-GELLED DISPOS ELECTRODE Advance Tech Intl. DRX Class II 1983-12-22
K830016 VASCUTEK VASCULAR PROTHESIS VP1200K/50K Pacesetter Systems DSY Class II 1983-12-21
K831768 EXTERNAL PULSE GENERATOR FOR TEMP. STIM Oscor, Inc. DTE Class II 1983-12-16
K832516 MAGNATRODE CARDIAC MONITORING ELECTRODE R2 Corp. DRX Class II 1983-12-16
K834096 IMPLANTABLE PULSE GENERATOR Intermedics, Inc. DXY Class III 1983-12-16
K833965 8 FRENCH DILATOR 15CM, W/LUER LOCK Quinton, Inc. DRE Class II 1983-12-16
K833322 TUBING CONNECTORS EC-2XXX SERIES Gish Biomedical, Inc. DTL Class II 1983-12-16
K833647 PACEMAKER SYS ANALYZER #384 Pacesetter Systems KRE Class II 1983-12-16
K832421 BATTERY-OPERATED ELECTROCARDIOGRAPH Somatronix Research Corp. DPS Class II 1983-12-16
K833479 WILLIAM HARVEY H-71-5-F CARDIOTOMY C.R. Bard, Inc. DTN Class II 1983-12-16
K823934 CARIEL F12 Odam DYC Class II 1983-12-16
K832050 MORTARA INSTRUMENT #101 Mortara Instrument, Inc. DPS Class II 1983-12-13
K832882 DIF-STET Intersect Systems, Inc. DQD Class II 1983-12-06
K832883 MINI-PECG Intersect Systems, Inc. DPS Class II 1983-12-06
K832374 PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH Sonicaid, Inc. JOM Class II 1983-12-01
K831676 BIOSENSOR ASC SYSTEM Biosensor Corp. DSI Class II 1983-12-01
K833253 SHILEY M2000 MEMBRANE OXYGENATOR Shiley, Inc. DTZ Class II 1983-12-01
K833823 HOLTER PERFORMER FEATHER WEIGHT/CASS Applied Cardiac Systems DSH Class II 1983-12-01
K833798 OPTIMA MDT PULSE GENERATOR W/TELEMETRY Telectronics, Inc. DXY Class III 1983-12-01
K831164 PATIENT MONITOR CM 135 Honeywell, Inc. DRT Class II 1983-12-01
K833271 NAMIC CONTINUOUS FLUSH DEVICE North American Instrument Corp. DRS Class II 1983-12-01
K833824 ENDOCARDIAL SCREW-IN LEAD 859 & 861 Pacesetter Systems DTB Class III 1983-12-01
K832227 G-2000 Eaton Medical Group DPS Class II 1983-12-01
K832380 PROTECTIVE SLEEVE Vertex Medical Corp. DYG Class II 1983-11-28
K833661 ELECTROCARDIOCORDER RECORDER 453 Del Mar Avionics DSH Class II 1983-11-28
K833112 TUBING FOR CARDIOPULMONARY BYPASS Cardio Med Supplies, Inc. DWF Class II 1983-11-28
K832035 SERVOMED COMPACT MONITOR SMK 155-9 Litton Medical Electronics DRT Class II 1983-11-16
K831782 SERVOMED BASIC BEDSIDE UNIT SMV 107 Litton Medical Electronics DXJ Class II 1983-11-16
K832022 SERVOMED SMC 108/111-426-24, 111-426 Litton Medical Electronics DXJ Class II 1983-11-16
K832021 SERVOMED COMPACT MONITOR SMK 154-8/101 Litton Medical Electronics DRT Class II 1983-11-16
K831783 SERVOMED BASIC BEDSIDE UNIT SMV 104 Litton Medical Electronics DXJ Class II 1983-11-16
K831781 SERVOMED BASIC BEDSIDE UNIT SMVIII W Litton Medical Electronics DXJ Class II 1983-11-16
K832131 SERVOMED CENTRAL STATION SMV 206 Litton Medical Electronics DRT Class II 1983-11-16
K832914 PRIMA-UNIPOLAR CARDIAC PULSE GENERAT Intermedics, Inc. DXY Class III 1983-11-14
K831638 SINGLE BED ARRHYTHMIA MONITOR AM500 Lifeline Systems, Inc. DSI Class II 1983-11-14
K833138 DIGITAL INJECTOR SYS Sybron Corp. DXT Class II 1983-11-14
K832959 PACEMAKER SYS. ANALYZER 378 Siemens Elema AB KRE Class II 1983-11-14
K832384 BP TRANSDUCER HOLDERS TH-2,3 & 4 American Bentley DXO Class II 1983-11-14
K833458 CASE-II Marquette Electronics, Inc. DPS Class II 1983-11-14
K833470 PACEMAKER EVALUATION MODULE-330 Marquette Electronics, Inc. DPS Class II 1983-11-07
K832657 DISPOSABLE MANIFOLD SET Mallinckrodt Critical Care DRS Class II 1983-11-07
K832656 DINAMAP VITAL SIGNS MONITOR #1846P Critikon Company, LLC DXN Class II 1983-11-07
K831134 PHOENIX 60/60 PROCESSOR MODULE Phoenix Corp. DSF Class I 1983-11-07
K832693 ARRHYTHMIA III CARDULE #1919 Spacelabs, Inc. DSI Class II 1983-11-07
K833096 TRANSDUCER DOME DS106 Sorensen Research DRS Class II 1983-11-03

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