510(k) K102109

ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 by Eurosets S.R.L — Product Code DTZ

K102109 is an FDA 510(k) premarket notification submitted by Eurosets S.R.L for the device "ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012". The FDA issued a decision of Substantially Equivalent on February 15, 2011. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Eurosets S.R.L has at least 5 other 510(k) clearances on record.