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510(k) Data Aggregation

    K Number
    K984482
    Device Name
    AVE GL-1 GUIDING CATHETER
    Date Cleared
    1999-07-30

    (226 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.
    Device Description
    The GL-1 catheter is a guiding catheter for use in the vascular system. Guide catheters provide a pathway through which dilatation systems and other interventional devices are introduced. Similar to the Mainstay Guiding catheters, the GL-1 Guiding catheter will be available in 6 French - 8 French, and will be offered in various curve styles.
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