510(k) K070798

ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS by Coeur, Inc. — Product Code DXT

K070798 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS". The FDA issued a decision of Substantially Equivalent on October 4, 2007. 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.