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510(k) K251715

FlowArt® Vial Access Device Vented by Asset Medikal — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2025
Date Received
June 4, 2025
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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