NIE — Catheter, Hemodialysis, Triple Lumen, Non-Implanted Class II
FDA product code NIE covers "Catheter, Hemodialysis, Triple Lumen, Non-Implanted", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NIE
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232945 | medical components, inc. (dba medcomp) | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | November 16, 2023 |
| K222170 | health line international corporation | Power Acute Triple Lumen Hemodialysis Catheter | January 13, 2023 |
| K183219 | medical components, inc. (dba medcomp) | Trio-CT Triple Lumen Catheter | June 14, 2019 |
| K181175 | medical components, inc. (dba medcomp) | 12F Tri-Flow Triple Lumen Catheter | July 5, 2018 |
| K143102 | arrow international, inc. (subsidiary of teleflex, inc.) | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | July 24, 2015 |
| K141531 | c.r. bard | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | June 1, 2015 |
| K133456 | c.r. bard | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | September 24, 2014 |
| K123292 | medcomp | T3 | June 11, 2013 |
| K102605 | covidien, llc, formerly registered as tyco healthca | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | December 22, 2010 |
| K083675 | c.r. bard | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER | March 19, 2009 |
| K033570 | medcomp | MEDCOMP T-3 | September 16, 2004 |
| K020089 | kendall | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | April 10, 2002 |