510(k) K022450

INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY by Dideco S.P.A. — Product Code DTZ

K022450 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY". The FDA issued a decision of Substantially Equivalent on Oct 22, 2002. 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 32 other 510(k) clearances on record.