510(k) K051799

DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS by Coeur, Inc. — Product Code DXT

K051799 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS". The FDA issued a decision of Substantially Equivalent on November 2, 2005. 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.