510(k) K240940

Vial2Bag Advanced® 20mm Admixture Device by West Pharmaceutical Services, Inc. — Product Code LHI

K240940 is an FDA 510(k) premarket notification submitted by West Pharmaceutical Services, Inc. for the device "Vial2Bag Advanced® 20mm Admixture Device". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. West Pharmaceutical Services, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2024
Date Received
April 5, 2024
Clearance Type
Special
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