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510(k) K142527

Extension Set with BD Q-Syte Luer Access Split Septum by Acacia, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2014
Date Received
September 8, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Acacia, Inc.

  • K122449 — ENTERAL NUTRITION WARMER (June 13, 2013)
  • K111381 — MEDI-SIS SYRINGE INFUSION SYSTEM (January 13, 2012)
  • K103165 — BLOOD SAMPLING SET (November 10, 2010)
  • K092986 — ACACIA PISTON SYRINGE (October 27, 2009)
  • K972538 — FLOW-EZE BLUNT CANNULA (1999BC) (July 15, 1998)
  • K931095 — SPRING LOADED SYRINGE (September 16, 1993)
  • K912771 — ACACIAS PHARM/PUMP (February 14, 1992)
  • K901063 — LUER LOCK TRANSFER PIN (July 6, 1990)
  • K896990 — PHARMULATOR (March 23, 1990)
  • K894206 — INTOPO (October 27, 1989)

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