LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130142

    Validate with FDA (Live)

    Device Name
    FLIXENE IFG VASCULAR GRAFT
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Date Cleared
    2013-03-15

    (52 days)

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

    The Atrium Flixene IFG 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 is a 510(k) clearance letter from the FDA for a vascular graft. It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device. Therefore, I cannot fulfill your request based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1