510(k) K232037 ยท PNE Reprocessed Catheter Introducer
Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Apr 4, 2024 |
| Received | Jul 10, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232037
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.