510(k) K201099
K201099 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD PhaSeal Optima Closed System Drug Transfer Device". The FDA issued a decision of Substantially Equivalent on Aug 12, 2020. The device falls under product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System), a Class II device regulated under 21 CFR 880.5440. Becton, Dickinson And Company has 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 2020
- Date Received
- Apr 24, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.