510(k) K212370

Leaderflex Mini and Leaderflex Nano by Vygon USA — Product Code FOZ

K212370 is an FDA 510(k) premarket notification submitted by Vygon USA for the device "Leaderflex Mini and Leaderflex Nano". The FDA issued a decision of Substantially Equivalent on August 29, 2022. 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. Vygon USA has at least 3 other 510(k) clearances on record.