BEUDAMED
    Product Code: PDI

    Beta 2-Microglobulin Apheresis Column

    Unknown

    The Beta 2-Microglobulin Apheresis Column is an extracorporeal blood treatment device used to provide relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA) by selectively removing beta 2-microglobulin from the patient's blood during dialysis. The device carries a class of "f," indicating a special or biological regulatory pathway, with no assigned regulation number or standard medical specialty. It was reviewed by an unspecified panel. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PDI
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    6

    Device Characteristics

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

    Definition

    Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.