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510(k) Data Aggregation

    K Number
    K252011

    Validate with FDA (Live)

    Date Cleared
    2026-02-02

    (220 days)

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

    This guide wire 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 guide wire is intended for use only in the neuro vasculature.

    Device Description

    The basic structure of the CHIKAI Nexus petit consists of a hybrid tapered core wire in which Ni-Ti alloy and stainless steel (SUS) is conjoined via Ni-Ti pipe. The distal part of the core wire is surrounded by the Pt-Ni (platinum-nickel) coil, soldered with Au-Sn (gold-tin) alloy. For the proximal coil, the joint section is covered by a tube made of Ni-Ti alloy. Within the tube, the stainless steel and Ni-Ti core wires are connected with ASAHI's proprietary stainless-steel coil, soldered with Au-Sn alloy and silver.

    In addition, coatings are applied on the surface of the device. The distal coil section is coated with a polyurethane coating. The hydrophilic coating is applied from the distal tip, on top of the polyurethane coating, to the proximal shaft.

    The maximum nominal outer diameter of the CHIKAI Nexus petit is 0.33 mm (0.013"). The diameter is tapered towards the distal tip with the nominal diameter of 0.16mm (0.006"). The CHIKAI Nexus petit's radiopaque distal tip (up to 8cm from the tip) enables the user to view the position of the tip under X-ray fluoroscopy.

    The device is available in length of 220cm with tip-shape variations of Straight, Round-curve and J-shape design.

    AI/ML Overview

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