BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

    K Number: K243264 · Decision Apr 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    61
    Review Days
    192

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    Basic Information

    Device Name
    DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
    K Number
    K243264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Italia S.R.L.
    Date Received
    October 15, 2024
    Decision Date
    April 25, 2025
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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