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

    SafeBreak Vascular

    K Number: DEN190043 · Decision May 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    617

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    Basic Information

    Device Name
    SafeBreak Vascular
    K Number
    DEN190043
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.5220
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Site Saver, Inc. D/B/A Lineus Medical
    Date Received
    September 18, 2019
    Decision Date
    May 27, 2021
    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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