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

    D100 KIDS; D101 KIDS

    K Number: K231652 · Decision Nov 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    61
    Review Days
    163

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    Basic Information

    Device Name
    D100 KIDS; D101 KIDS
    K Number
    K231652
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Italia S.R.L.
    Date Received
    June 6, 2023
    Decision Date
    November 16, 2023
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Sorin Group Italia S.R.L.

    K Number Device Name
    K253671 Dual Stage Venous Cannulae
    K251783 Inspire HCR and HCR DUAL cardiotomy reservoirs
    K253616 ProtekDilate Vascular Access Kit
    K250610 Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
    K250150 VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
    K243264 DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
    K242953 KIDS Arterial Filters
    K242092 MICRO Arterial Filters
    K241236 XTRA Collection sets; XTRA Sequestration set X
    K240584 XTRA Autotransfusion System (with XTRA Bowl sets)
    Search all 61 clearances from Sorin Group Italia S.R.L. →