510(k) K132928

MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE by Medrad, Inc. / Bayer Medical Care, Inc. — Product Code DXT

K132928 is an FDA 510(k) premarket notification submitted by Medrad, Inc. / Bayer Medical Care, Inc. for the device "MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE". The FDA issued a decision of Substantially Equivalent on January 23, 2014. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Medrad, Inc. / Bayer Medical Care, Inc. has at least 1 other 510(k) clearance on record.