# K181175: 12F Tri-Flow Triple Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc. (dba MedComp)
- Decided: Jul 5, 2018 after 64 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: 2 generations back to K973561 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033570: Medcomp T-3, Medcomp (2004) Summary page 4.

## Indications for use
The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein or femoral vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.

Source page: https://510kreport.com/device/K181175
Methodology: https://510kreport.com/methodology