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510(k) Data Aggregation

    K Number
    K250203
    Device Name
    SureAx-Guide™
    Manufacturer
    SureAx Medical, LLC
    Date Cleared
    2025-10-17

    (266 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K091385
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SureAx-Guide guidewire is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature. The SureAx-Guide guidewire is not intended for use in the coronary or neuro vasculature.

    Device Description

    The SureAx-Guide™ guidewire is comprised of a stainless-steel wire with a PTFE coating and distal coils and soldered tip. The distal end has a urethane sheath and PVP-based hydrophilic coating. The maximum outside diameter is 0.0142 inches and it will be available in 135cm and 190cm lengths. It will be supplied sterile and intended for single use.

    AI/ML Overview

    N/A

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