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Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

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.

Global Registration Data
Multi-Country Intelligence
Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
Cardiovascular Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QXV

View Product Code Classification

Class 2

21 CFR 870.5720

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Cardiovascular

Device Characteristics

No

No

No

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.