510(k) K250305 ยท PNE Reprocessed Catheter Introducer
Reprocessed Agilis NxT Steerable Introducer
| Applicant | Innovative Health, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Feb 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250305
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.