Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
QXV · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5720
Classification
FDA Product Code
QXV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.5720
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.