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

    Nautilus Smart ECMO Module

    K Number: K191935 · Decision Apr 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    265

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    Basic Information

    Device Name
    Nautilus Smart ECMO Module
    K Number
    K191935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mc3 Incorporated
    Date Received
    July 19, 2019
    Decision Date
    April 9, 2020
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BYS), ordered by most recent decision date.

    Nautilus VF ECMO Oxygenator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TUBING PACK, EXTRACORPOREAL, H-3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Mc3 Incorporated

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    K182914 MC3 Vascular Access Kit 21030
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    K171610 MC3 QuickFlow Dual Lumen Catheter