BEUDAMED
    Product Code: KNR FDA class 2 21 CFR 876.5540

    Adapter, A-V Shunt Or Fistula

    Gastroenterology, Urology

    An A-V Shunt or Fistula Adapter is a connector device used in hemodialysis to link arteriovenous shunts or fistulas to dialysis blood lines, enabling repeated vascular access for patients with end-stage renal disease undergoing regular dialysis treatment. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNR and the applicable regulation is 21 CFR 876.5540 in the Gastroenterology and Urology specialty. This device is an implant.

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

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    Basic Information

    Product Code
    KNR
    Device Class
    FDA class 2
    Regulation Number
    876.5540
    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
    K811851 S-610 SHUNT ADAPTOR SET