510(k) K010478

DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR by Dideco — Product Code DTZ

K010478 is an FDA 510(k) premarket notification submitted by Dideco for the device "DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR". The FDA issued a decision of Substantially Equivalent on Sep 27, 2001. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Dideco has 32 other 510(k) clearances on record.