BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Filter, Intravascular, Cardiovascular

    PMA: P850049 · Supplement: S008 · Decision Feb 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Filter, Intravascular, Cardiovascular
    Trade Name
    GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER
    PMA Number
    P850049
    Supplement Number
    S008
    Device Class
    FDA Class 2
    Product Code
    DTK
    Generic Name
    FILTER, INTRAVASCULAR, CARDIOVASCULAR
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 13, 2002
    Date Received
    June 13, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK INC., BLOOMINGTON, INDIANA.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTK Filter, Intravascular, Cardiovascular