Cleared Traditional

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

K173773 · Bayer Medical Care, Inc. · Cardiovascular

Aug 2018

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K173773 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 August 17, 2018, 248 days after receiving the submission on December 12, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K173773 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2017
Decision Date	August 17, 2018
Days to Decision	248 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF