# K080557: Barrx Models HALO360 and HALO360+ Coagulation Catheters

- Pathway: 510(k) (Special)
- Applicant: Barrx Medical, Incorporated
- Decided: Apr 2, 2008 after 34 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: 15 generations back to K943450 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071543: HALO360' Coagulation Catheter, Barrx Medical, Incorporated (2007) Summary page 2.
- K062225: Halo Coagulation Catheter, Barrx Medical, Incorporated (2006) Summary page 2.

## Indications for use
The HALO 360 Coagulation Catheter is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. The HALO 360 Coagulation 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/K080557
Methodology: https://510kreport.com/methodology