Vial2Bag Advanced 20mm Admixture Device
FDA 510(k) clearance K201415 · decided 2020-10-21
Clearance details
- K-number
- K201415
- Device name
- Vial2Bag Advanced 20mm Admixture Device
- Applicant
- West Pharmaceutical Services Az, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-29
- Decision date
- 2020-10-21
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/ recall (Z-0283-2025) | West Pharmaceutical Services AZ, Inc. | 2024-11-01 |