510(k) K243954 · DYB Introducer, Catheter
PeriCross Epicardial Access Kit
| Applicant | Circa Scientific, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Apr 24, 2025 |
| Received | Dec 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243954
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.