510(k) K111884

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

K111884 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME". The FDA issued a decision of Substantially Equivalent on July 29, 2011. 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.