The following data is part of a premarket notification filed by Abbott Medical with the FDA for Dragonfly Opstar™ Imaging Catheter, Aptivue™ Software Version E.5.1.
| Device ID | K192019 |
| 501k Number | K192019 |
| Device Name: | Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software Version E.5.1 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Abbott Medical 4 Robbins Road Westford, MA 01886 |
| Contact | Richard Demello |
| Correspondent | Richard Demello Abbott Medical 4 Robbins Road Westford, MA 01886 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Cardiovascular |
| 501k Review Panel | Cardiovascular |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2019-11-08 |