K192019 is an FDA 510(k) clearance for the Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Abbott Medical (Westford, US). The FDA issued a Cleared decision on November 8, 2019, 102 days after receiving the submission on July 29, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K192019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2019 |
| Decision Date | November 08, 2019 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |