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510(k) K113398

NEXUS TKO-6, LUER-ACTIVATED DEVICE by Nexus Medical, LLC — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2012
Date Received
November 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K092382 — NEXUS PRESSURE RATED EXTENSION SETS (April 26, 2010)
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  • K081123 — NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS (November 14, 2008)
  • K080976 — NEXUS I.V. FLUID TRANSFER DEVICE (November 10, 2008)
  • K062551 — NEXUS IRRIGATION TUBING SET (December 15, 2006)

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