510(k) K150902

330psi Extension Y-Line with Dual Check Valve by Coeur, Inc. — Product Code DXT

K150902 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "330psi Extension Y-Line with Dual Check Valve". The FDA issued a decision of Substantially Equivalent on October 22, 2015. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Coeur, Inc. has at least 10 other 510(k) clearances on record.