510(k) K014080

APEX ADULT HOLLOWE FIBER OXYGENATOR by Dideco S.P.A. — Product Code DTZ

K014080 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "APEX ADULT HOLLOWE FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on January 8, 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 at least 10 other 510(k) clearances on record.