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510(k) K123292

T3 by Medcomp — Product Code NIE

K123292 is an FDA 510(k) premarket notification submitted by Medcomp for the device "T3". The FDA issued a decision of Substantially Equivalent on June 11, 2013. The device falls under product code NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Medcomp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2013
Date Received
October 22, 2012
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)
  • 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)
  • K081904 — PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) (September 23, 2008)

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)
  • 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