510(k) K212370 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Leaderflex Mini and Leaderflex Nano
| Applicant | Vygon USA, Lansdale Montgomery PA, US |
| Decision | Substantially Equivalent, Aug 29, 2022 |
| Received | Jul 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212370
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.