510(k) K143481 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
IntellaMap Orion High Resolution Mapping Catheter
| Applicant | Rhythmia Medical, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jan 8, 2015 |
| Received | Dec 8, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143481
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.