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510(k) K121171

CUROS TIP by Ivera Medical, Inc. — Product Code QBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2012
Date Received
April 17, 2012
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 Ivera Medical, Inc.

  • K140657 — CUROS RED PORT PROTECTOR (December 4, 2014)
  • K111992 — CUROS PORT PROTECTOR (January 12, 2012)
  • K110826 — CUROS PORT PROTECTOR (June 23, 2011)

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)
  • K142806 — DualCap (May 22, 2015)
  • 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)