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510(k) K052790

SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD by Cardinal Health, Alaris Products — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2005
Date Received
October 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Cardinal Health, Alaris Products

  • K071400 — SMARTSITE STOPCOCK (December 14, 2007)
  • K071108 — TEXIUM SYRINGE (May 24, 2007)
  • K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS (July 26, 2006)
  • K053049 — ALARIS SAFETY MALE LUER (January 12, 2006)
  • K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001 (October 20, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K043590 — SE INFUSION SYSTEM WITH MMS (March 25, 2005)
  • K050230 — TURBO TEMP TRIO (February 16, 2005)

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