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510(k) K020089

MAHURKAR TRIPLE LUMEN CATHETER, 12 FR by The Kendall Company — Product Code NIE

K020089 is an FDA 510(k) premarket notification submitted by The Kendall Company for the device "MAHURKAR TRIPLE LUMEN CATHETER, 12 FR". The FDA issued a decision of Substantially Equivalent on April 10, 2002. The device falls under product code NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. The Kendall Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2002
Date Received
January 10, 2002
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 The Kendall Company

  • K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT (November 19, 2009)
  • K062671 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATE (November 3, 2006)
  • K061936 — KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 (August 9, 2006)
  • K060972 — KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALIND (August 4, 2006)
  • K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (January 6, 2006)
  • K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY (October 6, 2005)
  • K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP (December 22, 2004)
  • K042461 — KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 (December 10, 2004)
  • K042572 — KENDALL CO2NFIRM NOW CO2 DETECTOR (November 5, 2004)
  • K041914 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER (September 27, 2004)

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)
  • 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)

FDA data resources