BEUDAMED
    Product Code: FKD FDA class 2 21 CFR 876.5820

    Canister, Coil

    Gastroenterology, Urology

    The Coil Canister is a component of dialysis systems used to house the coil-type dialyzer through which blood passes during hemodialysis treatment. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKD, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

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

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    Basic Information

    Product Code
    FKD
    Device Class
    FDA class 2
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K790382 COIL DIALYSIS, MODELS DM-360 AND DM-360-