# K183219: Trio-CT Triple Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc. (dba MedComp)
- Decided: Jun 14, 2019 after 206 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: 10 generations back to K001901 (2000). 55 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123292: T3, Medcomp (2013) Summary page 5.

## Most influential descendants
- K232945: Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (2023), 0 descendants of its own

## Indications for use
The Trio-CT™ Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring,. The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K183219
Methodology: https://510kreport.com/methodology