XenoSure Dura Biologic Patch

XenoSure Dura Biologic Patch is an FDA 510(k)-cleared medical device (K183513) manufactured by LeMaitre Vascular, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2019. Regulation: 8.