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510(k) K133351

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2014
Date Received
October 31, 2013
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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  • K113398 — NEXUS TKO-6, LUER-ACTIVATED DEVICE (April 18, 2012)
  • K092382 — NEXUS PRESSURE RATED EXTENSION SETS (April 26, 2010)
  • K092930 — NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED (March 10, 2010)
  • K092527 — NEXUS INJECTION SITE, MODEL NIS-8 (February 4, 2010)
  • 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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