510(k) K211494 ยท 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, Sep 14, 2021 |
| Received | May 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211494
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.