BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Advanta VXT Vascular Graft, Flixene Vascular Graft

    K Number: K231972 · Decision Mar 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    269

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    Basic Information

    Device Name
    Advanta VXT Vascular Graft, Flixene Vascular Graft
    K Number
    K231972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atrium Medical Corporation
    Date Received
    July 3, 2023
    Decision Date
    March 28, 2024
    Product Code
    DSY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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    Other Clearances by Atrium Medical Corporation

    K Number Device Name
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    K151386 C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
    K151437 ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
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    K110110 ATRIUM CENTRILFX MESH