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

    LOPEZ VALVE

    K Number: K861586 · Decision Aug 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    66
    Review Days
    111

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    Basic Information

    Device Name
    LOPEZ VALVE
    K Number
    K861586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Icu Medical, Inc.
    Date Received
    April 29, 1986
    Decision Date
    August 18, 1986
    Product Code
    MJF
    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
    MJF Check Valve, Retrograde Flow (In-Line)

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