510(k) K223788

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter by Medsource International, LLC — Product Code FOZ

K223788 is an FDA 510(k) premarket notification submitted by Medsource International, LLC for the device "The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter". The FDA issued a decision of Substantially Equivalent on September 15, 2023. 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.