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

    DuraGraft Vascular Conduit Solution

    K Number: K240925 · Decision May 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    DuraGraft Vascular Conduit Solution
    K Number
    K240925
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4100
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marizyme
    Date Received
    April 4, 2024
    Decision Date
    May 1, 2024
    Product Code
    QEJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QEJ Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QEJ), ordered by most recent decision date.

    DuraGraft

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
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