Device Listing 1161549562

Listing Summary#

Listing key
1161549562
Premarket submission
K173773
Device
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
Applicant
Bayer Medical Care, Inc.
Product code
DXT
Decision date
2018-08-17