NIE · Class II · 21 CFR 876.5540

FDA Product Code NIE: Catheter, Hemodialysis, Triple Lumen, Non-implanted

Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion.

Leading manufacturers include C.R. Bard, Inc., Medical Components, Inc. (dba MedComp) and Medcomp.

12
Total
12
Cleared
190d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Catheter, Hemodialysis, Triple Lumen, Non-implanted Devices (Product Code NIE)

12 devices
1–12 of 12
Cleared Nov 16, 2023
Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
K232945
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 57d
Cleared Jan 13, 2023
Power Acute Triple Lumen Hemodialysis Catheter
K222170
Health Line International Corporation
Gastroenterology & Urology · 176d
Cleared Jun 14, 2019
Trio-CT Triple Lumen Catheter
K183219
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 206d
Cleared Jul 05, 2018
12F Tri-Flow Triple Lumen Catheter
K181175
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 64d
Cleared Jun 01, 2015
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
K141531
C.R. Bard, Inc.
Gastroenterology & Urology · 357d
Cleared Sep 24, 2014
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
K133456
C.R. Bard, Inc.
Gastroenterology & Urology · 316d
Cleared Jun 11, 2013
T3
K123292
Medcomp
Gastroenterology & Urology · 232d
Cleared Mar 19, 2009
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Sep 16, 2004
MEDCOMP T-3
K033570
Medcomp
Gastroenterology & Urology · 309d

About Product Code NIE - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code NIE since 2002, with 12 receiving FDA clearance (average review time: 190 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.