510(k) K113845

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE by Medtronic, Inc. — Product Code DTL

K113845 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE". The FDA issued a decision of Substantially Equivalent on January 25, 2012. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Medtronic, Inc. has at least 10 other 510(k) clearances on record.