510(k) K254248 ยท DYB Introducer, Catheter
Introducer Sheath Set
| Applicant | Cardiocycle Medical(Suzhou) Co., Ltd., Suzhou, Jiangsu, CN |
| Decision | Substantially Equivalent, Apr 23, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254248
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.