Mix2Vial® Transfer Device
FDA 510(k) clearance K231071 · decided 2024-01-19
Clearance details
- K-number
- K231071
- Device name
- Mix2Vial® Transfer Device
- Applicant
- West Pharma. Services IL, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-14
- Decision date
- 2024-01-19
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ra'Anana Central, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.