# K142364: Barrx RFA Self Sizing Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Oct 1, 2014 after 37 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K943450 (1995). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083711: Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34, Barrx Medical, Incorporated (2009) Summary page 5.
- K093855: Halo 360 & Sizing Balloon, Model 3441C, Barrx Medical, Incorporated (2010) Summary page 5.

## Indications for use
The Barrx™ RFA Self Sizing Balloon Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Source page: https://510kreport.com/device/K142364
Methodology: https://510kreport.com/methodology