510(k) K230376 ยท PNE Reprocessed Catheter Introducer
Reprocessed Agilis NxT Steerable Introducer
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Aug 7, 2023 |
| Received | Feb 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230376
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.