510(k) K161471

MR Syringe Dual Pack for Solaris Injectors by Coeur, Inc. — Product Code DXT

K161471 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "MR Syringe Dual Pack for Solaris Injectors". The FDA issued a decision of Substantially Equivalent on October 6, 2016. 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.