BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P210017 · Decision Sep 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    Cross-Seal Suture-Mediated Vascular Closure Device System
    PMA Number
    P210017
    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
    September 26, 2023
    Date Received
    April 29, 2021
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Cross-Seal Suture-Mediated Vascular Closure Device System. The device is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site while reducing time-to-hemostasis in patients who have undergone diagnostic or interventional catheterization procedures using 8F to 18F sheaths. The Cross-Seal System is indicated for one access site per leg.

    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