OPTION ELITE VENA CAVA FILTER SYSTEM

OPTION ELITE VENA CAVA FILTER SYSTEM is an FDA 510(k)-cleared medical device (K133243) 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 December 16, 2013. Regulation: 8.