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510(k) Data Aggregation

    K Number
    K240083
    Device Name
    GORE® PROPATEN® Vascular Graft
    Manufacturer
    W. L. Gore & Associates Inc.
    Date Cleared
    2024-03-01

    (50 days)

    Product Code
    DSY,DYF
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K232312
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

    Device Description

    The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a vascular graft. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document only discusses substantial equivalence to a predicate device based on similar technology, manufacturing, coating, sterilization, and intended use, with a minor update to the end-of-shelf-life Heparin Surface Activity specification.

    Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a training set from this document.

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