Power Acute Triple Lumen Hemodialysis Catheter
FDA 510(k) K222170 · Health Line International Corporation
510(k) numberK222170
Submission
- Device name
- Power Acute Triple Lumen Hemodialysis Catheter
- Applicant
- Health Line International Corporation
Slat Lake City, UT, US - Received
- July 21, 2022
- Decision date
- January 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NIE – Catheter, Hemodialysis, Triple Lumen, Non-Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Other 510(k)s with product code NIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsNIE · Traditional | Medical Components, Inc. (dba MedComp) | 11/16/2023SESK |
| K183219 | Trio-CT Triple Lumen CatheterNIE · Traditional | Medical Components, Inc. (dba MedComp) | 06/14/2019SEKD |
| K181175 | 12F Tri-Flow Triple Lumen CatheterNIE · Traditional | Medical Components, Inc. (dba MedComp) | 07/05/2018SESK |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsNIE · Traditional | Arrow International, Inc. (Subsidiary of… | 07/24/2015SEKD |
| K141531 | Power-Trialysis Slim-Cath Short-Term Dialysis CatheterNIE · Traditional | C.R. Bard, Inc. | 06/01/2015SEKD |
| K133456 | Power-Trialysis Short-Term Dialysis CatheterNIE · Traditional | C.R. Bard, Inc. | 09/24/2014SEKD |
| K123292 | T3NIE · Traditional | Medcomp | 06/11/2013SE |
| K102605 | Mahurkar Triple Lumen Dialysis CatheterNIE · Traditional | Covidien, LLC, Formerly Registered AS Tyco… | 12/22/2010SESK |
| K083675 | Power-Trialysis Triple Lumen Acute Dialysis CatheterNIE · Traditional | C.R. Bard, Inc. | 03/19/2009SE |
| K033570 | Medcomp T-3NIE · Traditional | Medcomp | 09/16/2004SE |
More from Medcomp
| 510(k) | Device | Decision |
|---|---|---|
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | 06/22/2026SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | 12/24/2020SESK |
| K200263 | Health Line CT Midline CatheterFOZ · Special | 03/12/2020SE |
| K192533 | Health Line CT CVCFOZ · Traditional | 12/10/2019SE |
| K160448 | ArtlineDQY · Traditional | 07/12/2016SE |
| K140270 | Nexus Midline CT CatheterFOZ · Traditional | 08/20/2014SE |
| K130851 | Cascade Hemodialysis/Apheresis CatheterMSD · Traditional | 01/09/2014SESK |
| K130034 | Uni-PiccLJS · Traditional | 03/08/2013SE |
| K120548 | Hlic Needle-Less ValveFPA · Traditional | 05/04/2012SE |
| K101329 | Synergy CT PiccLJS · Traditional | 08/19/2010SE |
Questions and answers
When was Power Acute Triple Lumen Hemodialysis Catheter cleared by the FDA?
Power Acute Triple Lumen Hemodialysis Catheter (K222170) received a 510(k) decision of Substantially Equivalent on January 13, 2023, 176 days after the submission was received.
What is the product code of K222170?
The FDA product code is NIE – Catheter, Hemodialysis, Triple Lumen, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.