510(k) K093986

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS by Sorin Group Italia S.R.L. — Product Code DTM

K093986 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS". The FDA issued a decision of Substantially Equivalent on January 22, 2010. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.