BD PhaSeal Optima Closed System Drug Transfer Device— 510(k) K201099
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K201099 for BD PhaSeal Optima Closed System Drug Transfer Device, Substantially Equivalent on 2020-08-12. Applicant: Becton, Dickinson and Company.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code ONB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Franklin Lakes, NJ, US
Adverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.