510(k) K090487

DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 by Coeur, Inc. — Product Code DXT

K090487 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150". The FDA issued a decision of Substantially Equivalent on October 19, 2009. 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.