EVA TPN CONTAINER
FDA 510(k) clearance K041415 · decided 2004-08-04
Clearance details
- K-number
- K041415
- Device name
- EVA TPN CONTAINER
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-27
- Decision date
- 2004-08-04
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363 recall (Z-1592-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |