The following data is part of a premarket notification filed by Bayer Medical Care Inc. with the FDA for Medrad Mark 7 Arterion Injection System.
| Device ID | K193028 |
| 510k Number | K193028 |
| Device Name: | MEDRAD Mark 7 Arterion Injection System |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Bayer Medical Care Inc. 1 Bayer Drive Indianola, PA 15051 |
| Contact | Kelly Frank |
| Correspondent | Kelly Frank 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 | 2019-10-30 |
| Decision Date | 2019-12-05 |