510(k) K201099 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
BD PhaSeal Optima Closed System Drug Transfer Device
| Applicant | Becton, Dickinson and Company, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Aug 12, 2020 |
| Received | Apr 24, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201099
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2025 | BD SWITZERLAND SARL BD PhaSeal Injector Luer (N30C), REF: 515001
BD PhaSeal Injector Luer Lock (N35), REF: 515003
BD PhaSeal Injector Luer Lock (N35C), REF: 515004
BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 51500 Open, Classified |
ONB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.