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

    Moda-flx Hemodialysis System™ Cartridge (102121-001 )

    K Number: K243607 · Decision Dec 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    Moda-flx Hemodialysis System™ Cartridge (102121-001 )
    K Number
    K243607
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diality, Inc.
    Date Received
    November 21, 2024
    Decision Date
    December 20, 2024
    Product Code
    FJK
    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
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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    Other Clearances by Diality, Inc.

    K Number Device Name
    K233798 Moda-flx Hemodialysis System and Cartridge