The following data is part of a premarket notification filed by Bayer Medical Care, Inc. with the FDA for Medrad Stellant Flex Ct Injection System With Certegra Workstation.
| Device ID | K192370 |
| 510k Number | K192370 |
| Device Name: | MEDRAD Stellant FLEX CT Injection System With Certegra Workstation |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Bayer Medical Care, Inc. 100 Bayer Blvd Whippany, NJ 07981 |
| Contact | Alison Maloney |
| Correspondent | Alison Maloney Bayer Medical Care, Inc. 100 Bayer Blvd Whippany, NJ 07981 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2019-12-13 |