BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TandemHeart Dual Lumen Cannula

    Reg #: 2531527 · FEI: 3002228812 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIAC ASSIST, INC.
    Registration Number
    2531527
    FEI Number
    3002228812
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    620 Alpha Dr
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160257

    Owner / Operator

    Firm Name
    CardiacAssist, Inc. dba TandemLife
    Operator Number
    9028561
    Address
    620 ALPHA DR.
    City
    Pittsburgh
    State
    PA
    Postal Code
    15238
    Country
    US
    Correspondent
    Jim Arbogast

    Products

    Device Name Product Code
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    TandemHeart Dual Lumen Cannula TandemHeart ProtekDUO Cannula TandemHeart Veno-Venous Cannula THVVC ProtekDUO THDLC

    Establishment Types

    Manufacture Device in the United States for Export Only