510(k) K033323

D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING by Dideco S.P.A. — Product Code DTZ

K033323 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING". The FDA issued a decision of Substantially Equivalent on January 13, 2004. 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.