510(k) K233207 · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Polaris X Unidirectional Steerable Diagnostic Catheter
| Applicant | Boston Scientific Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, Oct 27, 2023 |
| Received | Sep 28, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233207
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.