510(k) K193028

MEDRAD Mark 7 Arterion Injection System by Bayer Medical Care, Inc. — Product Code DXT

K193028 is an FDA 510(k) premarket notification submitted by Bayer Medical Care, Inc. for the device "MEDRAD Mark 7 Arterion Injection System". The FDA issued a decision of Substantially Equivalent on December 5, 2019. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Bayer Medical Care, Inc. has at least 9 other 510(k) clearances on record.