510(k) K103762

SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE by Sorin Group Deutschland GmbH — Product Code DTQ

K103762 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE". The FDA issued a decision of Substantially Equivalent on January 20, 2011. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Sorin Group Deutschland GmbH has at least 10 other 510(k) clearances on record.