DISPENSING PIN WITH ONE-WAY VALVE
FDA 510(k) clearance K943181 · decided 1994-09-29
Clearance details
- K-number
- K943181
- Device name
- DISPENSING PIN WITH ONE-WAY VALVE
- Applicant
- B. Braun of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-01
- Decision date
- 1994-09-29
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: recall (Z-1906-2016) | B. Braun Medical, Inc. | 2016-06-02 |
| Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiratio recall (Z-1907-2016) | B. Braun Medical, Inc. | 2016-06-02 |