510(k) K211438 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
OPTRELL Mapping Catheter with TRUEref Technology
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 18, 2022 |
| Received | May 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211438
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.