510(k) K240761

Arisure® Closed Male Luer with Spike Adapter (YM060) by Yukon Medical, LLC — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
March 20, 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