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

    BD PureHub Disinfecting Cap

    K Number: K193190 · Decision Nov 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    21
    Applicant Total
    134
    Review Days
    356

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    Basic Information

    Device Name
    BD PureHub Disinfecting Cap
    K Number
    K193190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    November 19, 2019
    Decision Date
    November 9, 2020
    Product Code
    QBP
    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
    QBP Cap, Device Disinfectant

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