510(k) K193237 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
Carto Octaray Mapping Catheter with Trueref Technology
| Applicant | Biosense Webster, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Jul 31, 2020 |
| Received | Nov 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193237
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.