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510(k) Data Aggregation

    K Number
    K992958
    Device Name
    ADVANTA GRAFT (<6MM)
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    1999-10-01

    (29 days)

    Product Code
    DYF
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K231972
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atrium (Wrapped) Advanta™ 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 (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) notification for the Atrium Advanta™ Graft does not contain the information needed to answer the questions about acceptance criteria and a study proving a device meets those criteria.

    This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It defines the "Indications for Use" for the device, but it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.
    • Training set details.

    The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study report.

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