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

    Actreen Hi-Lite Cath, Actreen Hi-Lite Set

    K Number: K180801 · Decision Nov 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    149
    Review Days
    222

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    Basic Information

    Device Name
    Actreen Hi-Lite Cath, Actreen Hi-Lite Set
    K Number
    K180801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Medical, Inc.
    Date Received
    March 28, 2018
    Decision Date
    November 5, 2018
    Product Code
    GBM
    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
    GBM Catheter, Urethral

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