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510(k) Data Aggregation

    K Number
    K102596
    Device Name
    ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2010-10-05

    (26 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT

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

    The Atrium Graduated Wall Flixene Ax-Bifem Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a vascular graft, which primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities. It does not include details about device performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.

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