# K251318: VariFuse Adjustable Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Jan 20, 2026 after 266 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K904788 (1990). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202347: UNIFUSE Infusion System with Cooper Wire, AngioDynamics, Inc. (2020) Summary page 5.

## Indications for use
The VariFuse Adjustable Infusion Catheter is indicated for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

Source page: https://510kreport.com/device/K251318
Methodology: https://510kreport.com/methodology