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510(k) K232945

Trio-CT­® Triple Lumen Catheter w/ Curved Extensions by Medical Components, Inc. (dba MedComp) — Product Code NIE

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 16, 2023
Date Received
September 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.

Other clearances by Medical Components, Inc. (dba MedComp)

  • K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (September 3, 2020)
  • K192807 — Duo-Flow Side x Side Double Lumen Catheter (April 23, 2020)
  • K183219 — Trio-CT Triple Lumen Catheter (June 14, 2019)
  • K181175 — 12F Tri-Flow Triple Lumen Catheter (July 5, 2018)
  • K173667 — 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 2 (May 17, 2018)
  • K180567 — C3 Wave System (April 12, 2018)
  • K170770 — CT Midline (July 25, 2017)

Other clearances for product code NIE

  • K222170 — Power Acute Triple Lumen Hemodialysis Catheter (January 13, 2023)
  • K183219 — Trio-CT Triple Lumen Catheter (June 14, 2019)
  • K181175 — 12F Tri-Flow Triple Lumen Catheter (July 5, 2018)
  • K143102 — Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (July 24, 2015)
  • K141531 — POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER (June 1, 2015)
  • K133456 — POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER (September 24, 2014)
  • K123292 — T3 (June 11, 2013)
  • K102605 — MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER (December 22, 2010)
  • K083675 — POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER (March 19, 2009)
  • K033570 — MEDCOMP T-3 (September 16, 2004)