510(k) K230620 · DQO Catheter, Intravascular, Diagnostic
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
| Applicant | Gentuity, LLC, Sudbury MA, US |
| Decision | Substantially Equivalent, Aug 8, 2023 |
| Received | Mar 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230620
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.