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

    SwabTip Male Disinfectant Cap

    K Number: K190918 · Decision Mar 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    332

    Basic Information

    Device Name
    SwabTip Male Disinfectant Cap
    K Number
    K190918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ICU Medical
    Date Received
    April 9, 2019
    Decision Date
    March 6, 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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