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510(k) Data Aggregation

    K Number
    K983927
    Device Name
    GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Date Cleared
    1999-03-11

    (126 days)

    Product Code
    DQT
    Regulation Number
    870.1370
    Why did this record match?
    Product Code :

    DQT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AVE guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
    Device Description
    The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.
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