510(k) K231312 · MTD Catheter, Intracardiac Mapping, High-Density Array
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 10, 2023 |
| Received | May 5, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231312
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.