510(k) K230988
K230988 is an FDA 510(k) premarket notification submitted by West Pharma. Services IL, Ltd. for the device "Vial2Bag Advanced® 13mm Admixture Device". The FDA issued a decision of Substantially Equivalent on December 1, 2023. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. West Pharma. Services IL, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2023
- Date Received
- April 6, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type