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

    BD Alaris™ Pump Epidural Infusion Set

    K Number: K221319 · Decision Jul 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    34
    Review Days
    441

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    Basic Information

    Device Name
    BD Alaris™ Pump Epidural Infusion Set
    K Number
    K221319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Care Fusion
    Date Received
    May 6, 2022
    Decision Date
    July 21, 2023
    Product Code
    PWH
    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
    PWH Administrations Sets With Neuraxial Connectors

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