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

    Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

    K Number: K250610 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    393
    Applicant Total
    2
    Review Days
    119

    Basic Information

    Device Name
    Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
    K Number
    K250610
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Livanova USA Inc
    Date Received
    February 28, 2025
    Decision Date
    June 27, 2025
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Livanova USA Inc

    K Number Device Name
    K233702 SMARxT Tubing and Connectors