510(k) K091007

AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 by Sorin Group Deutschland GmbH — Product Code DTQ

K091007 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05". The FDA issued a decision of Substantially Equivalent on July 2, 2009. 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.