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

    ClearLine IV

    K Number: K171954 · Decision Jan 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    210

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    Basic Information

    Device Name
    ClearLine IV
    K Number
    K171954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5445
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clearline MD
    Date Received
    June 29, 2017
    Decision Date
    January 25, 2018
    Product Code
    OKL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OKL Intravascular Administration Set, Automated Air Removal System

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