510(k) K192370

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation by Bayer Medical Care, Inc. — Product Code DXT

K192370 is an FDA 510(k) premarket notification submitted by Bayer Medical Care, Inc. for the device "MEDRAD Stellant FLEX CT Injection System with Certegra Workstation". The FDA issued a decision of Substantially Equivalent on December 13, 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.