510(k) K163513

Arrow Endurance Extended Dwell Peripheral Catheter System by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — Product Code FOZ

K163513 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) for the device "Arrow Endurance Extended Dwell Peripheral Catheter System". The FDA issued a decision of Substantially Equivalent on February 24, 2017. 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. Arrow International, Inc. (Subsidiary of Teleflex, Inc.) has at least 7 other 510(k) clearances on record.