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

    MC3 Crescent Jugular Dual Lumen Catheter

    K Number: K203409 · Decision May 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    165

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    Basic Information

    Device Name
    MC3 Crescent Jugular Dual Lumen Catheter
    K Number
    K203409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mc3, Inc.
    Date Received
    November 19, 2020
    Decision Date
    May 3, 2021
    Product Code
    PZS
    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
    PZS Dual Lumen Ecmo Cannula

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