510(k) K191170 ยท NLH Catheter, Recording, Electrode, Reprocessed
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Oct 30, 2019 |
| Received | May 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191170
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.