510(k) K211662 ยท NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Nov 18, 2021 |
| Received | Jun 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211662
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.