510(k) K901249

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR by Shiley, Inc. — Product Code DTZ

K901249 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on June 11, 1990. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Shiley, Inc. has at least 10 other 510(k) clearances on record.