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510(k) K143102

Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — Product Code NIE

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 24, 2015
Date Received
October 29, 2014
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 Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

  • K180395 — EZ-IO Intraosseous Vascular Access System (November 9, 2018)
  • K163513 — Arrow Endurance Extended Dwell Peripheral Catheter System (February 24, 2017)
  • K161313 — ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and An (August 24, 2016)
  • K160018 — Arrow Quickflash Arterial Catheterization Device (June 13, 2016)
  • K153487 — CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (February 4, 2016)
  • K153423 — CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (January 28, 2016)
  • K152272 — Arrow Endurance Extended Dwell Peripheral Catheter System (November 23, 2015)

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)
  • K181175 — 12F Tri-Flow Triple Lumen Catheter (July 5, 2018)
  • 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)