ClearanceBrief
510(k) K250059 · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)

ApplicantBecton, Dickinson and Company, Franklin Lakes NJ, US
DecisionSubstantially Equivalent, Sep 12, 2025
ReceivedJan 10, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250059

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.