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510(k) Data Aggregation

    K Number
    K124007
    Device Name
    SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
    Manufacturer
    MICRO THERAPEUTICS, INC D/B/A: EV3 INC
    Date Cleared
    2013-03-07

    (71 days)

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

    MICRO THERAPEUTICS, INC D/B/A: EV3 INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
    Device Description
    The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy. The following modifications have been made to the device: - Change in the degree of polymerization with the base coat . material. - . Elimination of Brown Oxide pigment from base coat material.
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