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510(k) K243404

HyHub™ and HyHub™ Duo Vial Access Devices by Takeda Pharmaceuticals — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2025
Date Received
November 1, 2024
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

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