510(k) K013915

D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER by Dideco S.P.A. — Product Code DTZ

K013915 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER". The FDA issued a decision of Substantially Equivalent on December 27, 2001. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Dideco S.P.A. has at least 10 other 510(k) clearances on record.