AF 840 PH.I.S.I.O. ARTERIAL FILTER

AF 840 PH.I.S.I.O. ARTERIAL FILTER is an FDA 510(k)-cleared medical device (K093601) manufactured by Sorin Group Italia S.R.L.. 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 17, 2009. Regulation: 8.