BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P230038 · Decision Jun 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    AbsorbaSeal 5.6.7F Vascular Closure Device
    PMA Number
    P230038
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 5, 2026
    Date Received
    November 17, 2023
    Expedited Review
    N

    Advisory Committee Statement

    the AbsorbaSeal 5.6.7F Vascular Closure Device. This device is indicated for use in percutaneous closure of femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures utilizing 5, 6, or 7F procedural sheaths.

    Classifications

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

    Product Code Device Name
    MGB Device, Hemostasis, Vascular