BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

    Reg #: 1124841 · FEI: 3000204839 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    17

    Registration Details

    Registration Name
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Registration Number
    1124841
    FEI Number
    3000204839
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    125 BLUE BALL RD
    City
    ELKTON
    State
    MD
    ZIP
    21921
    Country
    US

    Regulatory Submissions

    510(k) Number
    K922992

    Owner / Operator

    Firm Name
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Operator Number
    1828100
    Address
    6200 Jackson Road, --
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Lisa G Hessabi

    Products

    Device Name Product Code
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Tubing, Pump, Cardiopulmonary Bypass DWE
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Oxygenator, Cardiopulmonary Bypass DTZ
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Cardiovascular Procedure Kit OEZ
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Defoamer, Cardiopulmonary Bypass DTP
    Flowmeter, Blood, Cardiovascular DPW
    Laparoscope, General & Plastic Surgery GCJ
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Instruments, Surgical, Cardiovascular DWS
    Stabilizer, Heart MWS

    Proprietary Names

    CONDUCER CARDIOPLEGIA SET CDI H/S CUVETTE Tubing PUMP TUBING WITH X-COATING OVERPRESSURE SAFETY VALVE CAPIOX SP PUMP WITH X-COATING Terumo Capiox NX19 Oxygenator with Reservoir Cardiovascular Procedure Kit Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR CAPIOX CARDIOTOMY RESERVOIR VIRTUOSAPH Capiox iCP Centrifugal Pump TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM CAPIOX CIRCUIT CONNECTORS Stabilizer ADAPTERS WITH X-COATING VirtuoSaph Plus Endoscopic Vessel Harvesting System CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR CIRCUIT TUBINGS WITH X-COATING Gas B, Calibration Gas Gas A, Calibration Gas CAPIOX FLEXIBLE VENOUS RESERVOIR SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS Shunt Sensor Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir MCENDO550 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility