510(k) K121006 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, May 3, 2012 |
| Received | Apr 3, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121006
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.