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

About This 510(k) Submission

K113133 is an FDA 510(k) clearance for the MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION 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 December 15, 2011, 52 days after receiving the submission on October 24, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.