# K163356: Pulse* Spray Infusion System, Uni*Fuse Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: May 30, 2017 after 181 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961763 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961763: Pulse*Spray Infusion System, Angiodynamics, Div. E-Z-Em, Inc. (1996) Summary page 5.

## Recalls of this device
- Dec 18, 2023 · Class II · Z-1010-2024: Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

## Indications for use
The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature. The Uni*Fuse Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Source page: https://510kreport.com/device/K163356
Methodology: https://510kreport.com/methodology