510(k) K160303 ยท NLH Catheter, Recording, Electrode, Reprocessed
Reprocessed Polaris X Steerable Diagnostic EP Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, May 10, 2016 |
| Received | Feb 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160303
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.