# K192864: UNI*FUSE Infusion System with Cooper Wire

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jun 1, 2020 after 238 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: 19 generations back to K904788 (1990). 50 ancestors in all.
2 later devices descend 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)
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200, Thrombolex, Inc. (2019) Summary page 5.

## Most influential descendants
- K202347: UNIFUSE Infusion System with Cooper Wire (2020), 1 descendant of its own
- K251318: VariFuse Adjustable Infusion Catheter (2026), 0 descendants of its own

## Indications for use
The UNI*FUSE™ 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/K192864
Methodology: https://510kreport.com/methodology