510(k) K101740

ALBOSURE POLYESTER VASCULAR PATCH by LeMaitre Vascular, Inc. — Product Code DXZ

K101740 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "ALBOSURE POLYESTER VASCULAR PATCH". The FDA issued a decision of Substantially Equivalent on September 20, 2010. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.