510(k) K212165 ยท PNE Reprocessed Catheter Introducer
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Mar 10, 2022 |
| Received | Jul 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212165
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.