# K033570: Medcomp T-3

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Sep 16, 2004 after 309 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973561 (1998). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020089: Mahurkar Triple Lumen Catheter, 12 FR, The Kendall Company (2002) Summary page 1.
- K973561: Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 1M, Medical Components, Inc. (1998) Summary page 1.

## Most influential descendants
- K123292: T3 (2013), 2 descendants of its own
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K232945: Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (2023), 0 descendants of its own
- K181175: 12F Tri-Flow Triple Lumen Catheter (2018), 0 descendants of its own

## Indications for use
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR USE IN ATTAINING SHORT-TERM VASCULAR ACCESS FOR HEMODIALYSIS, APHERESIS AND INFUSION. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN. THE MEDCOMP® T-3 CATHETER IS INDICATED FOR A DURATION LESS THAN (30) DAYS.

Source page: https://510kreport.com/device/K033570
Methodology: https://510kreport.com/methodology