510(k) K001021

LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 by Dideco S.P.A. — Product Code DTZ

K001021 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902". The FDA issued a decision of Substantially Equivalent on Apr 25, 2000. 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.