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

    Nautilus VF ECMO Oxygenator

    K Number: K232767 · Decision Oct 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    Nautilus VF ECMO Oxygenator
    K Number
    K232767
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mc3, Inc.
    Date Received
    September 11, 2023
    Decision Date
    October 4, 2023
    Product Code
    BYS
    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
    BYS Oxygenator, Long Term Support Greater Than 6 Hours

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    Other Clearances by Mc3, Inc.

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    K203409 MC3 Crescent Jugular Dual Lumen Catheter