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

    Mix2Vial® Transfer Device

    K Number: K231071 · Decision Jan 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    280

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    Basic Information

    Device Name
    Mix2Vial® Transfer Device
    K Number
    K231071
    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
    April 14, 2023
    Decision Date
    January 19, 2024
    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
    K232875 Vial Adapter 20mm
    K230988 Vial2Bag Advanced® 13mm Admixture Device
    K230464 MixJect® Transfer Device
    K213513 Vented Vial Adapter 20mm