510(k) K161393 ยท NLH Catheter, Recording, Electrode, Reprocessed
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Oct 26, 2016 |
| Received | May 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161393
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.