QXV

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

Device class

Class II (moderate risk)

Regulation

21 CFR 870.5720

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 temperature regulation to control the temperature of the esophagus during cardiac ablation.

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