BEUDAMED
    Product Code: FJT FDA class 2 21 CFR 876.5820

    Intracatheter, Dialysis

    Gastroenterology, Urology

    The Dialysis Intracatheter is a device used to maintain access to the bloodstream during hemodialysis, functioning as an intravascular catheter within the dialysis circuit. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FJT, 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
    5
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    10

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    Basic Information

    Product Code
    FJT
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K863297 MODIFICATION'S TO TORAY'S B-2 SERIES
    K772148 CATHETER, FEMORAL VEIN, SF 6
    K772146 CATHETER, VEIN, FEMORAL, SF 10
    K770047 DNC 151 VINCA-FLO
    K760781 TRIEX-1 HOLLOW FIBER DIALYZER