510(k) K142660

Antegrade LeMills Valvulotome by LeMaitre Vascular, Inc. — Product Code MGZ

K142660 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "Antegrade LeMills Valvulotome". The FDA issued a decision of Substantially Equivalent on October 17, 2014. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.