BEUDAMED
    Product Code: FKB FDA class 2 21 CFR 876.5820

    Connector, Blood Tubing, Infusion T

    Gastroenterology, Urology

    The Infusion T Blood Tubing Connector is a T-shaped connector used to join blood tubing sections and allow infusion into the dialysis blood circuit. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKB, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

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    510(k)s
    2
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    11

    Basic Information

    Product Code
    FKB
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K891754 DC-4 SHUNT INFUSION T
    K771426 PEDIATRIC INFUSION T

    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.