# K232945: Trio-CT­® Triple Lumen Catheter w/ Curved Extensions

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc. (dba MedComp)
- Decided: Nov 16, 2023 after 57 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: 11 generations back to K001901 (2000). 56 ancestors in all.
No later device cites it as a predicate yet.
4 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183219: Trio-CT Triple Lumen Catheter, Medical Components, Inc. (dba MedComp) (2019) Summary page 5.

## 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 Sml/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K232945
Methodology: https://510kreport.com/methodology