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510(k) Data Aggregation

    K Number
    K253032

    Validate with FDA (Live)

    Device Name
    AXS Lift Intracranial Base Catheter
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2026-02-11

    (142 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K212838,K243593
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AXS Lift Intracranial Base Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

    Device Description

    The AXS Lift Intracranial Base Catheter ("AXS Lift") is a single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neurovasculature. The distal catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end. The distal end of the catheter contains tallow derivatives of bovine origin. It is packaged with one double port rotating hemostasis valve (RHV) and one peel-away introducer sheath. The peel-away introducer sheath is designed to protect the distal tip of the catheter during insertion into the short introducer sheath valve. The AXS Lift Intracranial Base Catheter is compatible with short introducer sheaths with an inner diameter of 7Fr or greater. AXS Lift is supplied sterile, non-pyrogenic, and is intended for single use only.

    AI/ML Overview

    N/A

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