# K201183: Vortex Radial Spray Catheter

- Pathway: 510(k) (Traditional)
- Applicant: CSA Medical, Inc.
- Decided: Dec 7, 2020 after 220 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K003811 (2001). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171626: truFreeze System, CSA Medical, Inc. (2017) Summary page 4.

## Indications for use
Intended Use: The truFreeze® System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196°C, requiring either active or passive venting during surgical procedures. Indications for Use, Vortex™ Radial Spray catheter: The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.

Source page: https://510kreport.com/device/K201183
Methodology: https://510kreport.com/methodology