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510(k) K033570

MEDCOMP T-3 by Medcomp — Product Code NIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2004
Date Received
November 12, 2003
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 Medcomp

  • K130889 — SPLIT CATH RG (April 28, 2014)
  • K123292 — T3 (June 11, 2013)
  • K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC (December 21, 2010)
  • K091954 — MICRO-STICK SET (January 8, 2010)
  • K091953 — PRO-PICC (September 16, 2009)
  • K092347 — PRO-PICC CT (September 16, 2009)
  • K090394 — VALVED TEARWAY INTRODUCER (September 1, 2009)
  • K091586 — VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN (July 23, 2009)
  • K091466 — 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 (June 17, 2009)
  • K081775 — THE MEDCOMP .010 VASCULAR GUIDEWIRES (March 25, 2009)

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)