510(k) K915183

SARNS 8000 MODULAR PERFUSION SYSTEM by 3M Health Care, Sarns — Product Code DTQ

K915183 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "SARNS 8000 MODULAR PERFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1992. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.