# K083737: Halo Ablation Catheter

- Pathway: 510(k) (Special)
- Applicant: Barrx Medical, Incorporated
- Decided: Feb 10, 2009 after 56 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.
22 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062723: HALO90 Coagulation Catheter, Barrx Medical, Incorporated (2006) Summary page 1.

## Most influential descendants
- K093008: Halo Ablation Catheter, Model 90-9100 (2010), 14 descendants of its own
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (2016), 6 descendants of its own
- K161202: C2 Cryoballoon Ablation System (2017), 5 descendants of its own
- K183595: Aqua Medical RF Vapor System (2019), 4 descendants of its own
- K163684: C2 CryoBalloon Ablation System (2018), 4 descendants of its own

## Indications for use
The HALO 90 System (inclusive of HALO 90 Ablation 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/K083737
Methodology: https://510kreport.com/methodology