BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P050043 · Decision Aug 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
    PMA Number
    P050043
    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
    August 20, 2007
    Date Received
    November 23, 2005
    Expedited Review
    N
    Docket Number
    07M-0344

    Advisory Committee Statement

    APPROVAL FOR THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5, 6, AND 8 FRENCH. THE DEVICE IS INDICATED AS FOLLOWS: THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE IS INTENDED FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, OR 8 FRENCH 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