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510(k) K243486

SmartSiteTM Vented Vial Access Device by Yukon Medical, LLC — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2024
Date Received
November 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Yukon Medical, LLC

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  • K201422 — Arisure Closed System Drug Transfer Device (CSTD) (March 2, 2021)
  • K172884 — Arisure Closed Vial Adapter (October 3, 2017)
  • K172631 — Arisure Dry Spike (September 29, 2017)
  • K171101 — Closed Male Luer (June 2, 2017)
  • K151963 — SmartSite Vented Vial Access Device (July 31, 2015)
  • K132863 — SMARTSITE VIALSHIELD (October 4, 2013)
  • K122265 — VIALOK SINGLE VIAL ACCESS DEVICE VENTED (August 14, 2012)
  • K121182 — VIALOK NON-VENTED (May 3, 2012)
  • K120799 — ARISURE NEUTRAL VALVE (March 30, 2012)

Other clearances for product code LHI

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  • K243404 — HyHub™ and HyHub™ Duo Vial Access Devices (July 18, 2025)
  • K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) (March 21, 2025)
  • K243985 — Rio™ Drug Reconstitution Transfer Device (January 22, 2025)
  • K241976 — nextaro® va, 15mm, 5µm (September 6, 2024)
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  • K232987 — FlowArt Valve for Vial Access (June 26, 2024)
  • K240940 — Vial2Bag Advanced® 20mm Admixture Device (May 3, 2024)