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. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Bayer Medical Care, Inc. (Indianaola, 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 FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K182273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2018 |
| Decision Date | November 01, 2018 |
| Days to Decision | 71 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |