meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1983-08-12

Clearances · page 171 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K831130 DISPOS. ABODOMINAL RETRACTING PAD Product Development Corp. DWF Class II 1983-08-12
K831443 PACELINE PATIENT TRANSMITTER MODEL 324 Pacesetter Systems DXH Class II 1983-08-12
K832409 LIFELINE PACING LEADS #471-07 &09 Intermedics, Inc. DTB Class III 1983-08-12
K830292 BIOELECTRICAL IMPEDANCE ANALYZER #101 Rjl Systems, Inc. DSB Class II 1983-08-12
K830914 EXTERNAL VALVE FUNCTION BLOCK Honeywell, Inc. DRQ Class II 1983-08-12
K831867 PRESSURE MONITORING IV BOTTLE CAP Alto Development Corp. DRS Class II 1983-08-12
K832110 ELECTRODE LEADS 030-267 & 030-268 Telectronics, Inc. DTB Class III 1983-08-12
K832075 ELECTRONIC BLOOD PRESS. METER-ZH-820P Panasonic Co. Div. Matsu Elec. Corp. America DXN Class II 1983-08-12
K832178 AMPLATZ HEPARIN COATED CATHETER Cook, Inc. DQY Class II 1983-08-12
K831945 ELECATH BALTHERM TLC THERMAL DILUTION Electro-Catheter Corp. DYG Class II 1983-08-12
K832245 UNIPOLAR-E ENDOCARDIAL TINED LEAD Cook Pacemaker Corp. DTB Class III 1983-08-12
K831769 VARIOUS CARDIOVASCULAR SURGICAL DEVICE Research Industries Corp. DWF Class II 1983-08-12
K832124 CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI Med-West, Inc. DWF Class II 1983-08-12
K830754 BLOOD PRESSURE MONITORING KITS,WALRUS Medical Parameters, Inc. DXT Class II 1983-08-12
K831759 INTRACARDIA SUCKERS Research Industries Corp. DWF Class II 1983-08-12
K831698 DISPOSABLE PRESSURE TRANSDUCER#14004195 Norton Performance Plastics Corp. DRS Class II 1983-08-11
K831151 PANASONIC MODEL EW-213 Panasonic Co. Div. Matsu Elec. Corp. America DXN Class II 1983-08-11
K830682 CARDIVAN BLOOD PRESSURE MONITOR Paramed Technology, Inc. DXN Class II 1983-08-11
K831966 CARDIOPLEGIA RESERVOIR-#500926 American Bentley DTN Class II 1983-08-11
K831955 HR 100T Thought Technology , Ltd. JOM Class II 1983-08-11
K832323 EDSLAB PRESSURE GAUGE American Edwards Laboratories MAV Class II 1983-08-11
K831330 UNIVERSAL CORONARY CANNULA Possis Medical, Inc. DWF Class II 1983-08-10
K832052 MODEL 327T UNIPOLAR CARDIAC PULSE GEN Cook Pacemaker Corp. DXY Class III 1983-08-08
K832064 VENOUS CATHETER Cardio Search, Inc. DQY Class II 1983-08-08
K831949 PROSTHETIC RINGS #4400 MITRAL & 4500 American Edwards Laboratories KRH Class II 1983-07-29
K830907 AMBULATORY ECG EVENT RECORDER Brentwood Instruments, Inc. DSH Class II 1983-07-28
K831232 LIFESTAT 200 Physio-Control Corp. DXN Class II 1983-07-28
K831001 UNICUFF-BLOOD PRESSURE CUFF Frontier Products DXQ Class II 1983-07-28
K831645 TEMP. BIPOLAR EPICARDIAL LEAD Cordic Corp. LDF Class II 1983-07-26
K831750 PM-3 Delta Medical Industries DXS Class II 1983-07-26
K831879 UNIVERSAL LEVEL SENSOR 3M Health Care, Sarns DTW Class II 1983-07-26
K830903 CARDIO ARRHYTHMIA TRANSMITTER C.A.T Cardio Technology , Ltd. DXH Class II 1983-07-26
K831767 IMPLANTABLE CARDIAC PACING LEADS Oscor, Inc. DTB Class III 1983-07-26
K832099 MEDTRONIC MODELS 4012 & 4512 Medtronic Vascular DTB Class III 1983-07-26
K830796 THE BLOOM STETHOSCOPE Stethophonics, Inc. LDE Class I 1983-07-19
K831337 COMPRESSAR DISPOSABLE DISC Instromedix, Inc. DQO Class II 1983-07-19
K831092 PECGASYS REMOTE TRANSMISSION UNIT Datamedix DXH Class II 1983-07-19
K830543 VASCULAR GRAFT PROSTHESIS EXPANDED MICR Impra, Inc. DSY Class II 1983-07-19
K831583 GP-303 Hirata Sangyo Co. USA, Inc. DXN Class II 1983-07-19
K831807 CATHETER INSERTION TRAYS, VARIOUS #'S American Pharmaseal Div. Ahsc DQY Class II 1983-07-18
K831705 WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD C.R. Bard, Inc. DTZ Class II 1983-07-18
K831677 HYPER-HYPOTHERMIA UNIT HYPO 10-200 Gambro, Inc. DWC Class II 1983-07-18
K830666 APNEA/BRADYCARDIA MONITOR HB 95 Harvey-Bostwick, Inc. DPS Class II 1983-07-18
K830604 WEDGE PRESSURE CATHETER Plasmedics, Inc. DYG Class II 1983-07-18
K831729 PERCUTANEOUS CATHETER INSERTION TRAY American Pharmaseal Div. Ahsc DQY Class II 1983-07-18
K831730 CONTINUOUS FLUSH DEVICE American Pharmaseal Div. Ahsc KRA Class II 1983-07-18
K831839 STAINLESS STEEL GUIDE WIRE Quinton, Inc. DQX Class II 1983-07-18
K822633 MICROVEL DOUBLE VELOUR SUPPORTED 100 Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1983-07-12
K831216 COMMAND ULTRA II Cardiac Pacemakers, Inc. DXY Class III 1983-07-12
K830916 VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR Bib, Inc. DRT Class II 1983-07-07
K831455 LEATHER VALVE CUTTER American V. Mueller DWS Class I 1983-07-07
K830915 OMAR Oxford Medilog, Inc. DSH Class II 1983-07-07
K831515 DINAMAP VITAL SIGNS MONITOR #1846 Critikon Company, LLC DXN Class II 1983-06-30
K831591 AORTIC ROOT CANNULA W/INTEGRAL PRESS Dlp, Inc. DWF Class II 1983-06-30
K831332 ARGYLE DUAL STAGE VENOUS RETURN CATH. Sherwood Medical Co. DWF Class II 1983-06-30
K831528 MODEL TP THERMISTOR PROBE Scimed Life Systems, Inc. DRF Class II 1983-06-30
K830634 CARDIOTOMY FILTER Texas Medical Products, Inc. JOD Class II 1983-06-30
K831717 CORONARY INFUSION CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1983-06-30
K831637 ACCU-FLUSH Accu-Line KRA Class II 1983-06-30
K831562 SONTEK INFUSION CATHETER Sontek Corp. DQO Class II 1983-06-30
K831529 CCS MODEL SJ-103 IMPLANTABLE ATRIAL Cardiac Control Systems, Inc. DTB Class III 1983-06-30
K831563 CORONARY GUIDING CATHETER-MODIFIED Advanced Cardiovascular Systems, Inc. DQY Class II 1983-06-30
K830791 UNIVERSAL MEDDARS SYSTEM Electronics For Medicine, Inc. DPS Class II 1983-06-22
K830885 GOULD MODEL IM3000-IM3100 BATTERY POWER Gould, Inc. DRT Class II 1983-06-22
K830830 CIRCA MED TWO-CHANNEL Circadian, Inc. DSI Class II 1983-06-18
K831393 VASCULAB BLOOD PRESSURE CUFF Medasonics, Inc. DXQ Class II 1983-06-16
K831479 METAL-BACKED ACETABULAR CUP Dow Corning Corp. Healthcare Industries Materials DXQ Class II 1983-06-15
K831161 COMMAND ULTRA I Cardiac Pacemakers, Inc. DXY Class III 1983-06-15
K830517 CENTRAL STATION DISPLAY/RECORDER MATRIX Marquette Electronics, Inc. DRT Class II 1983-06-15
K830892 THERMODILUTION CARDIAC OUTPUT COMPUTER- American Edwards Laboratories DXG Class II 1983-06-15
K830655 QUIK-SILVER RESTING ECG ELECTRODE Quinton, Inc. DRX Class II 1983-06-15
K831403 LOW PROFILE STEERABLE BALLOON DILATA Advanced Cardiovascular Systems, Inc. LIT Class II 1983-06-08
K831435 VENTRICULAR PACING LEADS MODELS 865/867 Pacesetter Systems DTB Class III 1983-06-08
K831436 UNIPOLAR ATRIAL J PACING LEAD MODEL 869 Pacesetter Systems DTB Class III 1983-06-08
K830587 VITAL SIGNS MONITOR 2 Physio-Control Corp. DRT Class II 1983-06-08
K831509 ANGIOGRAPHY KIT W/ADDIT. COMPONENTS Mallinckrodt Critical Care DQO Class II 1983-06-08
K830713 LS-1 PORTABLE BLOOD PRESSURE COMPUTER Vita-Stat Medical Services, Inc. DXN Class II 1983-06-08
K831286 ULTIPORE PREBYPASS PLUS FILTER Pall Biomedical Products Co. KRJ Class II 1983-06-08
K830858 BIO-PROBE SYSTEM-BLOOD FLOW PROBE Bio Medicus, Inc. DPT Class II 1983-06-08
K831261 SCI MED TUBING CONNECTORS Scimed Life Systems, Inc. DTL Class II 1983-06-03
K831260 SCI MED TEMPERATURE MONITORING ADAPTOR Scimed Life Systems, Inc. DTL Class II 1983-06-03
K830362 INFANT ELECTRODE BELT Sentry Medical Products, Inc. DRX Class II 1983-06-03
K830321 VENTURE II MONITORING SYSTEM Rae Medical Corp. DSF Class I 1983-06-03
K830628 REAL-TIME SPECTRUM ANALYZER Diagnostic Electronics Corp. DXG Class II 1983-06-02
K831348 FLUID ADMIN. SET AFS-1C Linton Biomed Corp. DRS Class II 1983-05-27
K831185 CARDIAC OUTPUT MEASURE SYSTEM Cook, Inc. DYG Class II 1983-05-27
K831225 GAS-STAT MONITORING SYSTEM Cardiovascular Devices, Inc. DRY Class II 1983-05-27
K830344 SIEMENS-ELMA PULSE GENERATOR #718 Burditt & Calkins-Siemens-Elema DXY Class III 1983-05-27
K830577 LINEAR PUMP #4370975 Wright Linear Pump, Inc. JOW Class II 1983-05-25
K830862 NEDS-01 & EPR-500 Biotronik Sales, Inc. DXY Class III 1983-05-25
K831122 WILLIAM HARVEY H-1700 ADULT BLOOD OXYG- C.R. Bard, Inc. DTZ Class II 1983-05-25
K831171 DIGICATH Argon Medical Corp. DQO Class II 1983-05-25
K823904 MODEL 515 NEO-TRAK NEONATAL MONITOR Ge Medical Systems Information Technologies DRT Class II 1983-05-25
K830489 RECORDER DMI Diagnostic Medical Instruments DSH Class II 1983-05-25
K830639 HI FLEX D-700 MODULAR BUBBLE OXYGENA- Electromedics, Inc. DTZ Class II 1983-05-25
K831262 DATA IV AMBULATORY MONITOR Cardio-Scan of Texas DSH Class II 1983-05-25
K830566 CONVERTER UNIT FOR ECG TRACE DISPLAY Honeywell, Inc. DPS Class II 1983-05-25
K831303 TELECTRONICS #030-253 BIFURCATED William C. Nealon DTB Class III 1983-05-25
K830685 NORELCO DELUXE DIGITAL BLOOD PRESSURE North American Philips Corp. DXN Class II 1983-05-18
K830254 LIFE LINE Kb & Assoc. DXH Class II 1983-05-18

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