BARRIERBAC AND BARRIERBAC S
FDA 510(k) clearance K941536 · decided 1994-04-19
Clearance details
- K-number
- K941536
- Device name
- BARRIERBAC AND BARRIERBAC S
- Applicant
- Mallinckrodt Medical
- Decision
- Substantially Equivalent
- Date received
- 1994-03-30
- Decision date
- 1994-04-19
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Argyle, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: recall (Z-1867-2021) | Covidien, LP | 2021-06-16 |