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510(k) Data Aggregation

    K Number
    K965067
    Device Name
    DILATION CATHETER, BALLOON
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    1997-01-28

    (41 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    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 UDB Catheter is intended to dilate constricted areas of the urethra, prostatic urethra and ureters.

    Device Description

    The UDB Catheter is a combination over-the-wire, non-over-the-wire device. It consists of a two-lumen, catheter shaft with a molded bifurcation, a dilatation balloon and a Coudé tip. A 10 cc luer lock syringe is included in the tray.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document appears to be a 510(k) summary for a medical device (dilatation catheter) from 1996, focusing on safety and effectiveness, and establishing substantial equivalence to predicate devices. It lists device description, intended uses, and a statement that product testing was conducted, but it does not include details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement as requested.

    Therefore, I cannot provide the requested information.

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