Clearance Summary
Vial2Bag Advanced® 20mm Admixture Device received FDA 510(k) clearance under submission number K240940, sponsored by West Pharmaceutical Services, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-05-03.
- Submission: K240940
- Applicant / Sponsor: West Pharmaceutical Services, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2024-05-03
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.