BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Decision Jun 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASCULAR SOLUTIONS DUETT SEALING DEVICE
    PMA Number
    P990037
    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 22, 2000
    Date Received
    June 30, 1999
    Expedited Review
    N
    Docket Number
    00M-1390

    Advisory Committee Statement

    APPROVAL FOR THE VASCULAR SOLUTIONS DUETT(TM) SEALING DEVICE. THIS DEVICE IS INDICATED FOR SEALING FEMORAL ARTERIAL PUNCTURE SITES AND REDUCING TIME TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F-9F INTRODUCER SHEATH WITH AN OVERALL LENGTH NOT EXCEEDING 15.2 CM.

    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