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510(k) Data Aggregation

    K Number
    K955728
    Device Name
    CORDIS BILIARY STENT
    Manufacturer
    CORDIS CORP.
    Date Cleared
    1996-05-08

    (142 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K905720,K911581,K885180,K896163,K911292,K914277,K921191,K903858,K882610
    Why did this record match?
    Device Name :

    CORDIS BILIARY STENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cordis Biliary Stent intended ↓se is to maintain patency of a bile duct which is obstructed from malignant neoplasms.

    Device Description

    The Cordis Biliary Stent is a helical coil made of flexible radiopaque 5400 Grade Tantalum (Ta). The stent is available in 7.0 mm diameter size. The nominal expanded length of the stent is 1.5 cm and 3.0 cm. The stent is supplied mounted and crimped onto a balloon catheter delivery system, the size of which determines the delivered diameter of the stent.

    AI/ML Overview

    The provided text describes a medical device (Cordis Biliary Stent) and its intended use, but it does not contain information about acceptance criteria, a specific study proving it meets those criteria, or details regarding AI/algorithm performance. Therefore, I cannot generate the requested table and information.

    The document is a "Summary of Safety and Effectiveness" from 1996, which is a regulatory filing for a conventional medical device, not an AI or algorithm-based device. It focuses on demonstrating substantial equivalence to predicate devices through design, construction, indication for use, and performance characteristics (evaluated via in-vitro and in-vivo testing), rather than setting and proving performance against specific acceptance criteria in the manner you've described for AI/algorithm studies.

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