MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

About This 510(k) Submission

K182273 is an FDA 510(k) clearance for the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on November 1, 2018, 71 days after receiving the submission on August 22, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.