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510(k) K181175

12F Tri-Flow Triple Lumen Catheter by Medical Components, Inc. (dba MedComp) — Product Code NIE

K181175 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. (dba MedComp) for the device "12F Tri-Flow Triple Lumen Catheter". The FDA issued a decision of Substantially Equivalent (kit) on July 5, 2018. The device falls under product code NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. (dba MedComp) has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 5, 2018
Date Received
May 2, 2018
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)

  • K232945 — Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (November 16, 2023)
  • 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)
  • 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

  • K232945 — Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (November 16, 2023)
  • K222170 — Power Acute Triple Lumen Hemodialysis Catheter (January 13, 2023)
  • K183219 — Trio-CT Triple Lumen Catheter (June 14, 2019)
  • 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)

FDA data resources