LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K963782
    Device Name
    BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1997-05-02

    (224 days)

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

    The Bard Memotherm Transhepatic Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

    Device Description

    The Bard Memotherm Transhepatic Endoprosthesis is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard Memotherm Transhepatic Biliary Endoprosthesis pre-loaded on a unique delivery system. This 7 Fr. delivery system is compatible with a 7 Fr. introducer and accepts a .035" guidewire. The Bard Memotherm Transhepatic Biliary Endoprosthesis is available in various diameters and lengths. The Bard Memotherm Transhepatic Biliary Endoprosthesis is a metal mesh stent constructed of biocompatible nitinol. It is self-expanding and is packaged pre-mounted on a disposable delivery system. It will be available in expanded diameters of 7, 8, 9, 10 and 12mm and in lengths from 30mm to 110mm.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It describes the device, its intended use, and general performance characteristics but lacks specific quantitative acceptance criteria or detailed study methodologies, sample sizes, ground truth establishment, or expert involvement.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1