510(k) K904040

SOFTSHELL VENOUS RESERVOIR by C.R. Bard, Inc. — Product Code DTN

K904040 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "SOFTSHELL VENOUS RESERVOIR". The FDA issued a decision of Substantially Equivalent on December 6, 1990. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.