510(k) K920178

CARDIOTOMY RESERVOIR W/20 MICRON FILITER by Lifestream Int'L, Inc. — Product Code DTN

K920178 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "CARDIOTOMY RESERVOIR W/20 MICRON FILITER". The FDA issued a decision of Substantially Equivalent on May 13, 1993. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.