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510(k) Data Aggregation

    K Number
    K240871
    Device Name
    Synxess Neurovascular Guidewire
    Manufacturer
    Enlight Medical Technologies (Shenzhen) Co., Ltd.
    Date Cleared
    2024-11-18

    (234 days)

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

    Enlight Medical Technologies (Shenzhen) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.
    Device Description
    The Synxess Neurovascular Guidewire is available in diameters of 0.014 inch (0.35 mm) and 0.010 inch (0.25 mm) and has 200 cm length. The device is comprised of a core wire, coils, and coatings, and is supplied with a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The device is provided sterile and is for single use.
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