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510(k) Data Aggregation

    K Number
    K040667
    Device Name
    XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    2004-04-07

    (23 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K033537
    Predicate For
    K050534
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Xpert™ Biliary Stent is intended for use in the palliation of malignant strictures in the biliary tree.
    The Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

    Device Description

    The Xpert™ Biliary Stent is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding stent to the biliary tree.

    AI/ML Overview

    I'm sorry, but this document does not contain the information required to answer your request. The provided text is a 510(k) summary and FDA letter for the Xpert™ Biliary Stent, which is a medical device, not an AI/ML device. Therefore, it does not include data on acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, which are relevant to AI/ML device evaluations.

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