BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P010049 · Supplement: S010 · Decision May 25, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM
    PMA Number
    P010049
    Supplement Number
    S010
    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
    May 25, 2004
    Date Received
    December 2, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE DESIGN OF THE QUICKSEAL ARTERIAL CLOSURE SYSTEM TO ALLOW THE DELIVERY OF Q-FOAM HEMOSTATIC SPONGE THROUGH AN INTRODUCER DELIVERY SHEATH AND ELIMINATE THE DEPTH MARKET COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSEAL SURESHOT AND IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTATIS 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