510(k) K262674 ยท DYB Introducer, Catheter
Giranel Guiding Sheath Set
| Applicant | Kossel Medtech (Suzhou) Co., Ltd., Suzhou New District, CN |
| Decision | Substantially Equivalent, Oct 15, 2026 |
| Received | Jul 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262674
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.