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510(k) Data Aggregation

    K Number
    K180726
    Device Name
    Savion DLVR Guidewire, Savion FLX Guidewire
    Date Cleared
    2018-06-18

    (90 days)

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

    Boston Scientific Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Savion DLVR and Savion FLX Guidewires are intended to facilitate the placement of balloon dilaters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
    Device Description
    The Boston Scientific Savion DLVR and Savion FLX Guidewires with ICE® Hydrophilic Coating are available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm, 185 cm, or 300 cm. These guidewires contain a metal core wire. Varying tapers along the core wire and differing tip materials (spring coil or polymer) provide combinations of rail support and tip flexibility to address user requirements. The proximal core wire section of all models is coated with polytetrafluoroethylene (PTFE) for lubricity. The 182 cm and 185 cm guidewires are designed with an extension section for exchange of Over-the-Wire systems by using the AddWire™ Extension Wire (K030617). The 300 cm guidewires allow exchange of therapeutic devices without the use of an exchange system.
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