510(k) K112086

MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE by Medrad, Inc. — Product Code DXT

K112086 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE". The FDA issued a decision of Substantially Equivalent on October 14, 2011. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Medrad, Inc. has at least 10 other 510(k) clearances on record.