MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE

About This 510(k) Submission

K112086 is an FDA 510(k) clearance for the MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on October 14, 2011, 85 days after receiving the submission on July 21, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.