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510(k) Data Aggregation

    K Number
    K060124
    Device Name
    ATRIUM FLIXENE GRAFT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2006-03-30

    (71 days)

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

    The Atrium Flixene Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Flixene Graft use in aortocoronary bypass applications or for use as a patch.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a vascular graft device. It states the review of the premarket notification and the determination of substantial equivalence to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria or the study that proves the device meets such criteria. It is a regulatory clearance document, not a scientific study report or a summary of performance data.

    Therefore, I cannot provide the requested information. The sections you asked for, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information, are not present in this regulatory letter.

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