510(k) K254085 · DQK Computer, Diagnostic, Programmable
CARTO 3 EP Navigation System V9.0 with PIU Plus
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 18, 2026 |
| Received | Dec 18, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254085
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.