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

    Inspire HCR and HCR DUAL cardiotomy reservoirs

    K Number: K251783 · Decision Dec 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    61
    Review Days
    194

    Basic Information

    Device Name
    Inspire HCR and HCR DUAL cardiotomy reservoirs
    K Number
    K251783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Italia S.R.L.
    Date Received
    June 11, 2025
    Decision Date
    December 22, 2025
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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