APTUS HELI-FX AORTIC SECUREMENT SYSTEM

APTUS HELI-FX AORTIC SECUREMENT SYSTEM is an FDA 510(k)-cleared medical device (K130677) manufactured by Aptus Endosystems, 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 April 11, 2013. Regulation: 8.