The following data is part of a premarket notification filed by Bayer Medical Care Inc. with the FDA for Mrxperion Mr Injection System, Mrxperion Mr Injection System Syringe Kit.
| Device ID | K143538 |
| 510k Number | K143538 |
| Device Name: | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258008165 | K143538 | 000 |
| 00616258008158 | K143538 | 000 |
| 00616258008141 | K143538 | 000 |
| 00616258008134 | K143538 | 000 |
| 10616258005055 | K143538 | 000 |
| 00616258021690 | K143538 | 000 |
| 00616258021355 | K143538 | 000 |
| 40616258022640 | K143538 | 000 |
| 40616258024323 | K143538 | 000 |