510(k) K183513

XenoSure Dura Biologic Patch by LeMaitre Vascular, Inc. — Product Code GXQ

K183513 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "XenoSure Dura Biologic Patch". The FDA issued a decision of Substantially Equivalent on June 13, 2019. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.