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510(k) K024363

NEXUS INJECTION SITE (NIS), MODEL NIS-1 by Nexus Medical, LLC — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2003
Date Received
December 31, 2002
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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  • 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)

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