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510(k) Data Aggregation

    K Number
    DEN190043
    Device Name
    SafeBreak Vascular
    Date Cleared
    2021-05-27

    (617 days)

    Product Code
    Regulation Number
    880.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    Site Saver, Inc. d/b/a Lineus Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter. SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.
    Device Description
    SafeBreak® Vascular is used with peripheral intravenous (IV) catheters and installed for in-line use with an IV administration set. It connects between the IV administration tubing and the patient's peripheral IV access device. When excessive force is applied to the IV administration set, SafeBreak® Vascular separates at a force lower than the force required to dislodge the peripheral IV catheter or disrupt the IV securement dressing (4 ± 1 1bf). When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump, and blood flow is stopped from the patient's IV catheter. SafeBreak® Vascular may be used for a maximum of seven days.
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