K250059
- 510(k) number
- K250059
- Device name
- BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- Applicant
- Becton, Dickinson and Company NJ · US
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2025-09-12
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250059.pdf
Official FDA record: K250059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.