PTFE FLIXENE GRADUATED WALL GRAFT

PTFE FLIXENE GRADUATED WALL GRAFT is an FDA 510(k)-cleared medical device (K071923) manufactured by Atrium Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2007. Regulation: 8.