510(k) K243928 ยท DYB Introducer, Catheter
ViaOne Epicardial Access System
| Applicant | Cardiovia , Ltd., Nazareth, IL |
| Decision | Substantially Equivalent, Mar 20, 2025 |
| Received | Dec 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243928
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.