The following data is part of a premarket notification filed by Bayer Medical Care Inc. with the FDA for Medrad Mrxperion Mr Injection System And Mr Injection System Syringe Kit.
| Device ID | K182276 |
| 510k Number | K182276 |
| Device Name: | MEDRAD MRXperion MR Injection System And MR Injection System Syringe Kit |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Bayer Medical Care Inc. 1 Bayer Drive Indianola, PA 15051 |
| Contact | Katie Dillon |
| Correspondent | Katie Dillon 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 |
|---|---|---|
| 00616258026206 | K182276 | 000 |