LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122138
    Device Name
    ATRIUM FLIXENE IFG VASCULAR GRAFT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2012-08-17

    (29 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 FLIXENE IFG VASCULAR GRAFT

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

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

    Device Description

    Atrium Graduated Wall Flixene IFG Graft

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a vascular graft device, not an AI/ML medical device. Therefore, it does not contain the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies.

    The document discusses the substantial equivalence of the "Atrium Flixene IFG Vascular Graft" to a predicate device and its indications for use in arterial vascular reconstruction, segmental bypass, and arteriovenous vascular access.

    To provide the requested information, a document describing a study conducted on an AI/ML medical device would be necessary.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1