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510(k) K142806

DualCap by Catheter Connections, Inc. — Product Code QBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2015
Date Received
September 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Device Disinfectant
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time

Other clearances by Catheter Connections, Inc.

  • K142399 — DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (November 19, 2014)
  • K123967 — CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS (January 22, 2013)
  • K123065 — CATHETER CONNECTIONS DUALCAP SOLO (December 14, 2012)
  • K113842 — CATHETER CONNECTIONS' DUALCAP SOLO (January 27, 2012)
  • K112985 — CATHETER CONNECTIONS' DUALCAP DUO (November 9, 2011)
  • K093229 — CATHETER CONNECTIONS DUALCAP (April 8, 2010)

Other clearances for product code QBP

  • K251592 — SteriHub™ Disinfecting Device and Protective Cover (February 11, 2026)
  • K223914 — ACTIV™ Cap (April 5, 2024)
  • K193190 — BD PureHub Disinfecting Cap (November 9, 2020)
  • K200299 — Curos Jet Disinfecting Cap (October 29, 2020)
  • K192382 — CapKlenZ (April 20, 2020)
  • K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
  • K140657 — CUROS RED PORT PROTECTOR (December 4, 2014)
  • K142399 — DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (November 19, 2014)
  • K130975 — SWABCAP AND SWABFLUSH (December 24, 2013)
  • K123967 — CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS (January 22, 2013)