510(k) K072308

D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED by Sorin Group Italia S.R.L. — Product Code DTM

K072308 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED". The FDA issued a decision of Substantially Equivalent on September 12, 2007. 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.