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 |