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

    INSITUCAT VALVE STRIPPER

    K Number: K885046 · Decision Feb 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    13
    Review Days
    450

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    Basic Information

    Device Name
    INSITUCAT VALVE STRIPPER
    K Number
    K885046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Aesculap Instruments Corp.
    Date Received
    December 5, 1988
    Decision Date
    February 28, 1990
    Product Code
    DWQ
    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
    DWQ Stripper, Vein, External

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