# K202347: UNIFUSE Infusion System with Cooper Wire

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Sep 15, 2020 after 28 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: 20 generations back to K904788 (1990). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192864: UNI*FUSE Infusion System with Cooper Wire, AngioDynamics, Inc. (2020) Summary page 5.

## Most influential descendants
- K251318: VariFuse Adjustable Infusion Catheter (2026), 0 descendants of its own

## Indications for use
The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

Source page: https://510kreport.com/device/K202347
Methodology: https://510kreport.com/methodology