# K172511: Hickman TriFusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 20, 2018 after 242 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: 2 generations back to K830233 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041088: Trifusion, Model 0609190/0659350, C.R. Bard, Inc. (2004) Summary page 4.

## Indications for use
The Hickman® TriFusion™ 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® TriFusion™ catheters are designed for apheresis, and the administration of 1.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheresis procedures.

Source page: https://510kreport.com/device/K172511
Methodology: https://510kreport.com/methodology