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510(k) K222170

Power Acute Triple Lumen Hemodialysis Catheter by Health Line International Corporation — Product Code NIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2023
Date Received
July 21, 2022
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 Health Line International Corporation

  • K200426 — Acute Dual Lumen Hemodialysis Catheter (December 24, 2020)
  • K200263 — Health Line CT Midline Catheter (March 12, 2020)
  • K192533 — Health Line CT CVC (December 10, 2019)
  • K160448 — ARTLINE (July 12, 2016)
  • K140270 — NEXUS MIDLINE CT CATHETER (August 20, 2014)
  • K130851 — CASCADE HEMODIALYSIS/APHERESIS CATHETER (January 9, 2014)
  • K130034 — UNI-PICC (March 8, 2013)
  • K120548 — HLIC NEEDLE-LESS VALVE (May 4, 2012)
  • K101329 — SYNERGY CT PICC (August 19, 2010)
  • K060352 — HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS (May 31, 2006)

Other clearances for product code NIE

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