510(k) K230253 · MTD Catheter, Intracardiac Mapping, High-Density Array
OPTRELL Mapping Catheter with TRUEref Technology
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 2, 2023 |
| Received | Jan 31, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230253
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.