510(k) K243599

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) by Arrow International, LLC (A subsidiary of Teleflex, Inc.) — Product Code FOZ

K243599 is an FDA 510(k) premarket notification submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) for the device "Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)". The FDA issued a decision of Substantially Equivalent on March 14, 2025. 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, LLC (A subsidiary of Teleflex, Inc.) has at least 3 other 510(k) clearances on record.