# P150026: Heartlight Endoscopic Ablation System

- Pathway: PMA
- Applicant: Cardiofocus, Inc.
- Decided: Apr 1, 2016 after 246 days
- Product code: OAE (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 7, 2025 · Class II · Z-1307-2025: Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.

Source page: https://510kreport.com/device/P150026
Methodology: https://510kreport.com/methodology