510(k) K093601

AF 840 PH.I.S.I.O. ARTERIAL FILTER by Sorin Group Italia S.R.L. — Product Code DTM

K093601 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "AF 840 PH.I.S.I.O. ARTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on December 18, 2009. 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.