BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Flow Directed

    PMA: P810046 · Supplement: S212 · Decision May 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43

    Basic Information

    Device Name
    Catheter, Flow Directed
    Trade Name
    HIGHSAIL CORONARY DILATATION CATHETERS
    PMA Number
    P810046
    Supplement Number
    S212
    Device Class
    FDA Class 2
    Product Code
    DYG
    Generic Name
    CATHETER, FLOW DIRECTED
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 10, 2002
    Date Received
    March 11, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PACKAGING BY ELIMINATING THE FLUSHING TOOL AND REPLACING THE DISPENSER TUBING COIL.

    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