Catheter, Hemodialysis, Triple Lumen, Non-Implanted
The Triple Lumen Hemodialysis Catheter (Non-Implanted) is a short-term (less than 30 days) central venous access device used for hemodialysis and apheresis, with a third lumen available for infusion of medications or fluids. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIE and regulation 21 CFR 876.5540 in the Gastroenterology and Urology specialty. The device is flagged as life-sustaining/life-supporting due to its role in hemodialysis, and is not an implanted device given its short-term use.
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Basic Information
- Product Code
- NIE
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Nov 16, 2023 | Unknown | Medical Components, Inc. (dba MedComp) |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Jan 13, 2023 | Substantially Equivalent | Health Line International Corporation |
| K183219 | Trio-CT Triple Lumen Catheter | Jun 14, 2019 | Unknown | Medical Components, Inc. (dba MedComp) |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Jul 05, 2018 | Unknown | Medical Components, Inc. (dba MedComp) |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | Jul 24, 2015 | Unknown | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) |
| K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | Jun 01, 2015 | Unknown | C.R. Bard, Inc. |
| K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | Sep 24, 2014 | Unknown | C.R. Bard, Inc. |
| K123292 | T3 | Jun 11, 2013 | Substantially Equivalent | Medcomp |
| K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | Dec 22, 2010 | Unknown | Covidien, LLC, Formerly Registered AS Tyco Healthca |
| K083675 | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER | Mar 19, 2009 | Substantially Equivalent | C.R. Bard, Inc. |
| K033570 | MEDCOMP T-3 | Sep 16, 2004 | Substantially Equivalent | Medcomp |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | Apr 10, 2002 | Substantially Equivalent | The Kendall Company |
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.