BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Terumo Cardiovascular Costa Rica LLC

    Reg #: 3017987980 · FEI: 3017987980 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    Terumo Cardiovascular Costa Rica LLC
    Registration Number
    3017987980
    FEI Number
    3017987980
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calle 58
    City
    Zona Franca La Lima Cartago
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K150542

    Owner / Operator

    Firm Name
    Terumo Cardiovascular Systems Corp.
    Operator Number
    10039199
    Address
    6200 Jackson Road
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Lisa Hessabi

    US Agent

    Business Name
    Terumo Cardiovascular Systems Corp.
    Contact Name
    Lisa Hessabi
    Address
    6200 Jackson Rd
    City
    Ann Arbor
    State
    MI
    ZIP
    48103
    Country
    US
    Email
    [email protected]
    Phone
    734 7416324

    Products

    Device Name Product Code
    Cardiovascular Procedure Kit OEZ
    Tubing, Pump, Cardiopulmonary Bypass DWE
    Filter, Bacterial, Breathing-Circuit CAH
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Cpb Check Valve, Retrograde Flow, In-Line MJJ
    Transducer, Blood-Pressure, Extravascular DRS
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    Cardiovascular Procedure Kit Pump Tubing Breathing circuit filter Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass HEAT-EXCHANGER CPB Check Valve Breathing Circuit Catheter/Tubing

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device