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

    MC3 QuickFlow Dual Lumen Catheter

    K Number: K171610 · Decision Nov 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    168

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    Basic Information

    Device Name
    MC3 QuickFlow Dual Lumen Catheter
    K Number
    K171610
    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
    June 1, 2017
    Decision Date
    November 16, 2017
    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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    Other Clearances by Mc3 Incorporated

    K Number Device Name
    K191935 Nautilus Smart ECMO Module
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