DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150

About This 510(k) Submission

K090487 is an FDA 510(k) clearance for the DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on October 19, 2009, 236 days after receiving the submission on February 25, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.