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 Health Line International Corporation.

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 Mar 19, 2009
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675
C.R. Bard, Inc.
Gastroenterology & Urology · 98d

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.