APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE

APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE is an FDA 510(k)-cleared medical device (K141041) manufactured by Aptus Endosystems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 2014. Regulation: 8.