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

    Blood Administration Set

    K Number: K210335 · Decision Jun 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    29
    Applicant Total
    61
    Review Days
    125

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    Basic Information

    Device Name
    Blood Administration Set
    K Number
    K210335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corporation
    Date Received
    February 5, 2021
    Decision Date
    June 10, 2021
    Product Code
    BRZ
    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
    BRZ Set, Blood Transfusion

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