510(k) K072697

3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES by 3t Medical Systems, LLC — Product Code DTN

K072697 is an FDA 510(k) premarket notification submitted by 3t Medical Systems, LLC for the device "3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on December 20, 2007. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. 3t Medical Systems, LLC has at least 4 other 510(k) clearances on record.