510(k) K132190

EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME by LeMaitre Vascular, Inc. — Product Code MGZ

K132190 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME". The FDA issued a decision of Substantially Equivalent on August 5, 2013. 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.