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

    Catheter, Flow Directed

    PMA: P810046 · Supplement: S213 · Decision Oct 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43

    Basic Information

    Device Name
    Catheter, Flow Directed
    Trade Name
    ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS
    PMA Number
    P810046
    Supplement Number
    S213
    Device Class
    FDA Class 2
    Product Code
    DYG
    Generic Name
    CATHETER, FLOW DIRECTED
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 23, 2002
    Date Received
    September 27, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO A REVISED SAMPLING GROUP AND A PYROGEN SAMPLING PLAN FOR CORONARY DILATATION CATHETERS.

    Classifications

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

    Product Code Device Name
    DYG Catheter, Flow Directed