K190102 is an FDA 510(k) clearance for the DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction 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 October 17, 2019, 268 days after receiving the submission on January 22, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K190102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2019 |
| Decision Date | October 17, 2019 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| 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 |