510(k) K182386 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reprocessed Supreme Diagnostic Electrophysiology Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Apr 23, 2019 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182386
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.