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510(k) Data Aggregation

    K Number
    K024178
    Device Name
    VIATORR ENDOPROSTHESIS
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Date Cleared
    2003-03-07

    (79 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VIATORR® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

    Device Description

    The VIATORR Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface and radiopaque markers. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the VIATORR® Endoprosthesis, a tracheal prosthesis. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. The letter confirms substantial equivalence to predicate devices based on composition, design, intended use, and performance attributes, but no specific performance metrics, study designs, or ground truth establishment methods are detailed.

    Therefore, I cannot provide the requested information from this document.

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