510(k) K020997

APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR by Dideco S.P.A. — Product Code DTZ

K020997 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Apr 4, 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.