Option (TM) ELITE Vena Cava Filter 100cm System

Option (TM) ELITE Vena Cava Filter 100cm System is an FDA 510(k)-cleared medical device (K143405) manufactured by Rex Medical, L.P.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 2015. Regulation: 8.