# K973744: Unicath SP BI-Plane (Model M269 & M289)

- Pathway: 510(k) (Traditional)
- Applicant: Xre Corp.
- Decided: Dec 29, 1997 after 89 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- 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.

## Indications for use
The Unicath SP Biplane System is an Angiographic x-ray imaging system designed for those cardiac catheterization procedures requiring two simultaneous images of the heart and/or coronary arteries. Such systems are used to reduce the time necessary for complex adult cardiac catheterization studies, but they are particularly valuable in pediatric cardiology where biplane imaging allows reduced use of contrast material due to the need for fewer injections. This is a great advantage since contrast causes significant discomfort in children and carries with it an increased health risk for them. The System is designed to be operated by professional medical personnel only.

Source page: https://510kreport.com/device/K973744
Methodology: https://510kreport.com/methodology