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510(k) K140657

CUROS RED PORT PROTECTOR by Ivera Medical, Inc. — Product Code QBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2014
Date Received
March 14, 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 Ivera Medical, Inc.

  • K121171 — CUROS TIP (November 26, 2012)
  • K111992 — CUROS PORT PROTECTOR (January 12, 2012)
  • K110826 — CUROS PORT PROTECTOR (June 23, 2011)

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  • 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)
  • 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)