510(k) K901624

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. by Shiley, Inc. — Product Code DTZ

K901624 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.". The FDA issued a decision of Substantially Equivalent on July 3, 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.