T3
FDA 510(k) K123292 · Medcomp
510(k) numberK123292
Submission
- Device name
- T3
- Applicant
- Medcomp
Harleysville, PA, US - Received
- October 22, 2012
- Decision date
- June 11, 2013
- 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 |
| 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 |
| 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 |
| 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 |
|---|---|---|
| K130889 | Split Cath RGMSD · Traditional | 04/28/2014SESK |
| K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccLJS · Traditional | 12/21/2010SE |
| K091954 | Micro-Stick SetDYB · Traditional | 01/08/2010SE |
| K092347 | Pro-Picc CTLJS · Special | 09/16/2009SE |
| K091953 | Pro-PiccLJS · Traditional | 09/16/2009SE |
| K090394 | Valved Tearway IntroducerDYB · Traditional | 09/01/2009SE |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenLJS · Traditional | 07/23/2009SE |
| K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model VPI.9S20, VPI.9S50LJS · Special | 06/17/2009SE |
| K081775 | The Medcomp .010 Vascular GuidewiresDQX · Traditional | 03/25/2009SE |
| K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)LJS · Traditional | 09/23/2008SE |
Questions and answers
When was T3 cleared by the FDA?
T3 (K123292) received a 510(k) decision of Substantially Equivalent on June 11, 2013, 232 days after the submission was received.
What is the product code of K123292?
The FDA product code is NIE – Catheter, Hemodialysis, Triple Lumen, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.