# K951602: Pulse*Spray Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Angiodynamics, Div. E-Z-Em, Inc.
- Decided: Jun 14, 1995 after 92 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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).

Source page: https://510kreport.com/device/K951602
Methodology: https://510kreport.com/methodology