510(k) K252972 · DQK Computer, Diagnostic, Programmable
CARTO 3 EP Navigation System V8.4
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 20, 2026 |
| Received | Sep 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252972
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.