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510(k) Data Aggregation

    K Number
    K253746

    Validate with FDA (Live)

    Device Name
    Enroute 0.014'' Transcarotid Guidewire
    Manufacturer
    Lake Region Medical
    Date Cleared
    2026-03-19

    (114 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K160643
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Enroute Transcarotid 0.014" Guidewire is intended for use in the peripheral vasculature, inclusive of the carotid artery.

    Device Description

    The ENROUTE Transcarotid 0.014" Guidewire is a disposable medical device designed for single use only. It consists of a 95cm PTFE coated 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over approximately 9.5cm in a progressive fashion through a centerless grinding operation. The profile of this reduced section affords the product an area of reduced stiffness. The distal tip section is flattened to further reduce stiffness and enable the tip to be shaped. The distal section is covered with a 5cm platinum tungsten spring coil. This provides for greater visibility on x-ray equipment (radiopacity). A hydrophilic coating is applied to the distal section to enhance lubricity. The product is available in a straight configuration.

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