K143538 is an FDA 510(k) clearance for the MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on August 14, 2015, 242 days after receiving the submission on December 15, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K143538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2014 |
| Decision Date | August 14, 2015 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |