LIFESPAN EPTFE VASCULAR GRAFT

LIFESPAN EPTFE VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K130016) manufactured by LeMaitre Vascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 2013. Regulation: 8.