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 Health Line International Corporation and Medical Components, Inc. (dba 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
Cleared
Nov 16, 2023
Trio-CT® Triple Lumen Catheter w/ Curved Extensions
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology
57d
Cleared
Jan 13, 2023
Power Acute Triple Lumen Hemodialysis Catheter
Health Line International Corporation
Gastroenterology & Urology
176d
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.
NIE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →