BEUDAMED
    Product Code: LWZ FDA class 3

    Tissue Graft Of Less Than 6mm

    Unknown

    The Tissue Graft of Less Than 6mm (product code LWZ) is a small-diameter vascular or tissue graft used in cardiovascular surgical procedures to bypass or repair blood vessels where the graft diameter is less than 6mm. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to the risks of using small-diameter grafts in critical vascular applications. The device is reviewed under the Cardiovascular (CV) panel and has no formal regulation number. It is not flagged as an implant or life-sustaining device.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    0

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    Basic Information

    Product Code
    LWZ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K843149 KODAK T-MAT C FILM SO-119
    K843148 KODAK T-MAT H FILM SO-118