510(k) K252227 ยท DYB Introducer, Catheter
Pounce(TM) Sheath
| Applicant | Surmodics,Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Sep 24, 2025 |
| Received | Jul 16, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252227
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.