K193028 is an FDA 510(k) clearance for the MEDRAD Mark 7 Arterion Injection System. 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 December 5, 2019, 36 days after receiving the submission on October 30, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K193028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2019 |
| Decision Date | December 05, 2019 |
| Days to Decision | 36 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |