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

    BAROguard

    K Number: K223874 · Decision Aug 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    42
    Applicant Total
    5
    Review Days
    235

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    Basic Information

    Device Name
    BAROguard
    K Number
    K223874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paragonix Technologies
    Date Received
    December 23, 2022
    Decision Date
    August 15, 2023
    Product Code
    KDN
    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
    KDN System, Perfusion, Kidney

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    Other Clearances by Paragonix Technologies

    K Number Device Name
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