QXU

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Device class

Class II (moderate risk)

Regulation

21 CFR 870.5710

Medical specialty

Cardiovascular

FDA definition

This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy

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