BEUDAMED
    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    Device, Vascular, For Promoting Embolization

    PMA: P780011 · Decision May 15, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96

    Basic Information

    Device Name
    Device, Vascular, For Promoting Embolization
    Trade Name
    MINI BALLOON
    PMA Number
    P780011
    Device Class
    FDA Class 2
    Product Code
    KRD
    Generic Name
    Device, Vascular, for Promoting Embolization
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 15, 1980
    Date Received
    November 27, 1978
    Expedited Review
    N

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRD Device, Vascular, For Promoting Embolization