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

    15L Cycler Drainage Bag

    K Number: K214016 · Decision Mar 18, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    112
    Applicant Total
    61
    Review Days
    86

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    Basic Information

    Device Name
    15L Cycler Drainage Bag
    K Number
    K214016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corporation
    Date Received
    December 22, 2021
    Decision Date
    March 18, 2022
    Product Code
    KDJ
    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
    KDJ Set, Administration, For Peritoneal Dialysis, Disposable

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