510(k) K991737

LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR by Dideco S.P.A. — Product Code DTZ

K991737 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/NEWBORN HOLLOW FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Feb 17, 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.