AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS is an FDA 510(k)-cleared medical device (K093986) 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 January 21, 2010. Regulation: 8.