510(k) K911876

SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 by Shiley, Inc. — Product Code DTN

K911876 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200". The FDA issued a decision of Substantially Equivalent on August 9, 1991. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Shiley, Inc. has at least 10 other 510(k) clearances on record.