BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P120016 · Decision Jan 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASCADE VASCULAR CLOSURE SYSTEM
    PMA Number
    P120016
    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
    January 31, 2013
    Date Received
    August 3, 2012
    Expedited Review
    N
    Docket Number
    13M-0592

    Advisory Committee Statement

    APPROVAL FOR THE VASCADE¿ VASCULAR CLOSURE SYSTEM (VCS). THIS DEVICE IS INDICATED FOR FEMORAL ARTERIAL ACCESS SITE CLOSURE WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVEUNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F, 6F, OR 7F PROCEDURAL SHEATH. THE VASCADE VCS IS ALSO INDICATED TO REDUCE TIME TO DISCHARGE ELIGIBILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR PROCEDURES USING A 5F, 6F, OR 7F PROCEDURAL SHEATH.

    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