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

    SafeBreak Vascular

    K Number: K222791 · Decision Oct 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    SafeBreak Vascular
    K Number
    K222791
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5220
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lineus Medical, LLC
    Date Received
    September 15, 2022
    Decision Date
    October 16, 2022
    Product Code
    QOI
    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
    QOI Intravenous Catheter Force-Activated Separation Device.

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