BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Filter, Intravascular, Cardiovascular

    PMA: P850049 · Supplement: S009 · Decision Feb 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Filter, Intravascular, Cardiovascular
    Trade Name
    BIRD'S NEST VENA CAVA FILTER
    PMA Number
    P850049
    Supplement Number
    S009
    Device Class
    FDA Class 2
    Product Code
    DTK
    Generic Name
    FILTER, INTRAVASCULAR, CARDIOVASCULAR
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 3, 2006
    Date Received
    January 5, 2006
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE STERILIZATION TYPE WITHIN THE SAME FACILITY.

    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