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510(k) Data Aggregation

    K Number
    K121398
    Device Name
    CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
    Manufacturer
    GUIDEPATH MEDICAL, INC.
    Date Cleared
    2012-12-13

    (218 days)

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

    GUIDEPATH MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
    Device Description
    The Charlie Guidewire is a steerable guidewire that is compatible with .035" catheters and devices. Lengths are available from 70cm to 280cm. The guidewire is constructed from a Nitinol core wire with a polymer jacket. The jacket is coated with a hydrophilic polymer. The distal tip is atraumatic, and available in straight or various angled configurations. The main body is available in varying stiffness configurations. The device will be provided sterile and intended for one-time use. Product has a 2-year shelf life.
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