Power-Trialysis Slim-Cath Short-Term Dialysis Catheter
FDA 510(k) K141531 · C.R. Bard, Inc.
510(k) numberK141531
Submission
- Device name
- Power-Trialysis Slim-Cath Short-Term Dialysis Catheter
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- June 9, 2014
- Decision date
- June 1, 2015
- Decision
- Unknown (SEKD)
- 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 |
| K222170 | Power Acute Triple Lumen Hemodialysis CatheterNIE · Traditional | Health Line International Corporation | 01/13/2023SE |
| 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 |
| 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 |
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Questions and answers
When was Power-Trialysis Slim-Cath Short-Term Dialysis Catheter cleared by the FDA?
Power-Trialysis Slim-Cath Short-Term Dialysis Catheter (K141531) received a 510(k) decision of Unknown on June 1, 2015, 357 days after the submission was received.
What is the product code of K141531?
The FDA product code is NIE – Catheter, Hemodialysis, Triple Lumen, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.