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

    GENTLE HEADER

    K Number: K902845 · Decision Dec 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    158

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    Basic Information

    Device Name
    GENTLE HEADER
    K Number
    K902845
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Enhanced Perfusion Systems, Inc.
    Date Received
    June 28, 1990
    Decision Date
    December 3, 1990
    Product Code
    DWE
    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
    DWE Tubing, Pump, Cardiopulmonary Bypass

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