510(k) K063255

D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED by Sorin Group Italia S.R.L. — Product Code DTM

K063255 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED". The FDA issued a decision of Substantially Equivalent on January 11, 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.