510(k) K252766 ยท DYB Introducer, Catheter
14Fr Low Profile Introducer Kit
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Oct 8, 2025 |
| Received | Aug 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252766
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.