FDA product code QXV

Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

Cardiovascular·Class 2·21 CFR 870.5720
US regulatory classifications
US Product Code (FDA)
QXV
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.5720
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Temperature Regulation Device For Esophageal Protection During Cardiac Ablation is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.