510(k) K252309 ยท DYB Introducer, Catheter
PerQseal Introducers
| Applicant | Vivasure Medical Limited, Galway, IE |
| Decision | Substantially Equivalent, Oct 23, 2025 |
| Received | Jul 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252309
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.