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510(k) K231071

Mix2Vial® Transfer Device by West Pharma Services Il, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2024
Date Received
April 14, 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

Other clearances by West Pharma Services Il, Ltd.

  • K232875 — Vial Adapter 20mm (December 14, 2023)
  • K230988 — Vial2Bag Advanced® 13mm Admixture Device (December 1, 2023)
  • K230464 — MixJect® Transfer Device (May 22, 2023)
  • K213513 — Vented Vial Adapter 20mm (August 31, 2022)

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