BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P010049 · Decision Mar 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM
    PMA Number
    P010049
    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
    March 25, 2002
    Date Received
    September 10, 2001
    Expedited Review
    N
    Docket Number
    02M-0134

    Advisory Committee Statement

    APPROVAL FOR THE QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE DELIVERY OF GELFOAM FOR THE EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITE. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS. THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES.

    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