BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Zenysis Short-Term Dialysis Catheter

    K Number: K163458 · Decision Apr 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    645
    Review Days
    116

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    Basic Information

    Device Name
    Zenysis Short-Term Dialysis Catheter
    K Number
    K163458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    December 9, 2016
    Decision Date
    April 4, 2017
    Product Code
    MPB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPB Catheter, Hemodialysis, Non-Implanted

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