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

    14F Duo-Flow® Side X Side Double Lumen Catheter

    K Number: K250836 · Decision Aug 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    63
    Review Days
    145

    Basic Information

    Device Name
    14F Duo-Flow® Side X Side Double Lumen Catheter
    K Number
    K250836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc.
    Date Received
    March 20, 2025
    Decision Date
    August 12, 2025
    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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