# K041088: Trifusion, Model 0609190/0659350

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 1, 2004 after 189 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- 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 K830233 (1983). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830233: Non-Sterile,Single/Souble Lumen-Cath, Evermed, Inc. (1983) Summary page 1.

## Most influential descendants
- K172511: Hickman TriFusion Catheter (2018), 0 descendants of its own

## Indications for use
The Hickman® TriFusionTM Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular vein, and subclavian vein. All Hickman® TriFusionTM catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusionTM catheter incorporates three large, equal size lumens appropriate for apheresis procedures.

Source page: https://510kreport.com/device/K041088
Methodology: https://510kreport.com/methodology