510(k) K261530 ยท FPA Set, Administration, Intravascular
iiSure Infusion Set
| Applicant | Deka Research and Development, Manchester NH, US |
| Decision | Substantially Equivalent, Jun 3, 2026 |
| Received | May 8, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261530
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.