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

    ASK-300

    K Number: K882977 · Decision Jan 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    5
    Review Days
    174

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    Basic Information

    Device Name
    ASK-300
    K Number
    K882977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Repackers Co.
    Date Received
    July 15, 1988
    Decision Date
    January 5, 1989
    Product Code
    DQR
    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
    DQR Cannula, Catheter

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