510(k) K191880 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Dec 11, 2019 |
| Received | Jul 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191880
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.