510(k) K261281 ยท DQX Wire, Guide, Catheter
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
| Applicant | Filmecc Co., Ltd., Seto-Shi, JP |
| Decision | Substantially Equivalent, Sep 3, 2026 |
| Received | Apr 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261281
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.