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510(k) Data Aggregation

    K Number
    K063210
    Device Name
    ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
    Date Cleared
    2007-03-15

    (143 days)

    Product Code
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
    Device Description
    The Attain Hybrid Guide Wire is a single use guide wire designed to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. The guide wires consist of a core wire with springs, and coatings. Near the distal end of the device, the core wire consists of tapers to allow differing support or stiffness levels.
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