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510(k) K802561

HI VOLUME PUMPING CHAMBER by Acacia, Inc. — Product Code JTB

K802561 is an FDA 510(k) premarket notification submitted by Acacia, Inc. for the device "HI VOLUME PUMPING CHAMBER". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code JTB (Device, Media Dispensing/Stacking), a Class I device regulated under 21 CFR 866.2440. Acacia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Media Dispensing/Stacking
Device Class
Class I
Regulation Number
866.2440
Review Panel
MI
Submission Type

Other clearances by Acacia, Inc.

  • K142527 — Extension Set with BD Q-Syte Luer Access Split Septum (September 19, 2014)
  • 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)

Other clearances for product code JTB

  • K790514 — I NETILMICIN RIA KIT (May 3, 1979)

FDA data resources