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

    ANGIOPLASTY INFLATOR

    K Number: K911295 · Decision Jul 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    109

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    Basic Information

    Device Name
    ANGIOPLASTY INFLATOR
    K Number
    K911295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vastek
    Date Received
    March 25, 1991
    Decision Date
    July 12, 1991
    Product Code
    MAV
    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
    MAV Syringe, Balloon Inflation

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