510(k) K230411 · DQO Catheter, Intravascular, Diagnostic
Dragonfly OpStar Imaging Catheter
| Applicant | ABBOTT MEDICAL, Westford MA, US |
| Decision | Substantially Equivalent, Apr 14, 2023 |
| Received | Feb 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230411
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.