BEUDAMED
    Product Code: MCI FDA class 3

    Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

    Unknown

    The synthetic/biological composite hemodialysis access vascular graft is a cardiovascular device used to create an arteriovenous fistula or graft for vascular access in patients requiring hemodialysis, combining synthetic and biological materials to enhance performance. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MCI and no regulation number or formal medical specialty has been assigned; the device is not listed as an implant in this classification record. It does not sustain life.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MCI
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OB
    Submission Type
    2

    Device Characteristics

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