BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
FDA 510(k) clearance K140591 · decided 2014-05-14
Clearance details
- K-number
- K140591
- Device name
- BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2014-03-07
- Decision date
- 2014-05-14
- Days to decision
- 68 days
- Clearance type
- Special
- Product code
- ONB
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515 recall (Z-2453-2025) | BD SWITZERLAND SARL | 2025-08-27 |