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510(k) K172884

Arisure Closed Vial Adapter by Yukon Medical — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2017
Date Received
September 21, 2017
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

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  • K172631 — Arisure Dry Spike (September 29, 2017)
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  • 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)

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