BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P150006 · Decision Jul 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    CELT ACD VASCULAR CLOSURE DEVICE
    PMA Number
    P150006
    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
    July 20, 2016
    Date Received
    February 3, 2015
    Expedited Review
    N
    Docket Number
    16m-2185

    Advisory Committee Statement

    Approval for the Celt ACD Vascular Closure Device. This device is indicated for the percutaneous closure of common femoral artery puncture sites while reducing time-to-hemostasis in patients who have undergone diagnostic or interventional intra-arterial catheterization procedures where either 5F or 6F introducer sheaths have been used.

    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