Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
FDA 510(k) K143102 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
510(k) numberK143102
Submission
- Device name
- Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA, US - Received
- October 29, 2014
- Decision date
- July 24, 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.
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions cleared by the FDA?
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (K143102) received a 510(k) decision of Unknown on July 24, 2015, 268 days after the submission was received.
What is the product code of K143102?
The FDA product code is NIE – Catheter, Hemodialysis, Triple Lumen, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.