K163054 is an FDA 510(k) clearance for the DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Osprey Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 8, 2017, 127 days after receiving the submission on November 1, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K163054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2016 |
| Decision Date | March 08, 2017 |
| Days to Decision | 127 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 |