510(k) K123448

AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE by Medtronic, Inc. — Product Code DTL

K123448 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE". The FDA issued a decision of Substantially Equivalent on December 13, 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.