BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    MixJect® Transfer Device

    K Number: K230464 · Decision May 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    176
    Registration Numbers
    176
    Same Product Code
    200
    Applicant Total
    5
    Review Days
    90

    Basic Information

    Device Name
    MixJect® Transfer Device
    K Number
    K230464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    West Pharma Services IL, Ltd.
    Date Received
    February 21, 2023
    Decision Date
    May 22, 2023
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by West Pharma Services IL, Ltd.

    K Number Device Name
    K231071 Mix2Vial® Transfer Device
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