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510(k) Data Aggregation
K Number
DEN190043Device Name
SafeBreak Vascular
Manufacturer
Date Cleared
2021-05-27
(617 days)
Product Code
Regulation Number
880.5220Why 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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