ClearanceBrief
510(k) K261530 ยท FPA Set, Administration, Intravascular

iiSure Infusion Set

ApplicantDeka Research and Development, Manchester NH, US
DecisionSubstantially Equivalent, Jun 3, 2026
ReceivedMay 8, 2026
TypeSpecial
FDA recordOpen 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.