12F Tri-Flow Triple Lumen Catheter
FDA 510(k) K181175 · Medical Components, Inc. (dba MedComp)
510(k) numberK181175
Submission
- Device name
- 12F Tri-Flow Triple Lumen Catheter
- Applicant
- Medical Components, Inc. (dba MedComp)
Harleysville, PA, US - Received
- May 2, 2018
- Decision date
- July 5, 2018
- Decision
- Unknown (SESK)
- 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 |
| 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 |
|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsNIE · Traditional | 11/16/2023SESK |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD · Special | 09/03/2020SE |
| K192807 | Duo-Flow Side x Side Double Lumen CatheterMPB · Traditional | 04/23/2020SE |
| K183219 | Trio-CT Triple Lumen CatheterNIE · Traditional | 06/14/2019SEKD |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…MSD · Traditional | 05/17/2018SESK |
| K180567 | C3 Wave SystemLJS · Special | 04/12/2018SE |
| K170934 | C3 Wave SystemLJS · Traditional | 12/06/2017SE |
| K170770 | CT MidlinePND · Special | 07/25/2017SE |
Questions and answers
When was 12F Tri-Flow Triple Lumen Catheter cleared by the FDA?
12F Tri-Flow Triple Lumen Catheter (K181175) received a 510(k) decision of Unknown on July 5, 2018, 64 days after the submission was received.
What is the product code of K181175?
The FDA product code is NIE – Catheter, Hemodialysis, Triple Lumen, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.