510(k) K161779

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter by Medsource International, LLC — Product Code FOZ

K161779 is an FDA 510(k) premarket notification submitted by Medsource International, LLC for the device "MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter". The FDA issued a decision of Substantially Equivalent on November 3, 2016. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Medsource International, LLC has at least 9 other 510(k) clearances on record.