BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

    K Number: K200306 · Decision Mar 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
    K Number
    K200306
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott (Formerly Thoratec Corporation)
    Date Received
    February 6, 2020
    Decision Date
    March 6, 2020
    Product Code
    DWA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWA Control, Pump Speed, Cardiopulmonary Bypass

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