Product code QXV

Device name

Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.5720

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset