# K961763: Pulse*Spray Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Angiodynamics, Div. E-Z-Em, Inc.
- Decided: Jul 17, 1996 after 71 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
104 later devices descend from it; 3 cite it directly.
2 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K974067: Fountain Infusion  Catheter  and Occluding Guide Wire (1998), 101 descendants of its own
- K981417: Squirt Fluid Delivery System (1998), 95 descendants of its own
- K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length) (2002), 75 descendants of its own
- K021958: Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H (2002), 57 descendants of its own
- K023514: Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length) (2002), 56 descendants of its own

## Recalls of this device
- Aug 6, 2014 · Class II · Z-2261-2014: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
- Aug 6, 2014 · Class II · Z-2260-2014: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
- Aug 6, 2014 · Class II · Z-2262-2014: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

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

Source page: https://510kreport.com/device/K961763
Methodology: https://510kreport.com/methodology