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, 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,.
| Device ID | K182273 |
| 510k Number | K182273 |
| Device Name: | 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, |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Bayer Medical Care Inc. 1 Bayer Drive Indianola, PA 15051 |
| Contact | Lisa A. Ewing |
| Correspondent | Lisa A. Ewing Bayer Medical Care Inc. 1 Bayer Drive Indianola, PA 15051 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-22 |
| Decision Date | 2018-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258026473 | K182273 | 000 |
| 00616258025384 | K182273 | 000 |
| 00616258025377 | K182273 | 000 |
| 40616258026440 | K182273 | 000 |
| 40616258024811 | K182273 | 000 |
| 40616258024545 | K182273 | 000 |
| 40616258024538 | K182273 | 000 |
| 00616258022512 | K182273 | 000 |
| 00616258027340 | K182273 | 000 |