510(k) K133600

COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR by Coeur, Inc. — Product Code DXT

K133600 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR". The FDA issued a decision of Substantially Equivalent on April 30, 2014. 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.