510(k) DEN230021
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 13, 2023
- Date Received
- March 30, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
- Device Class
- Class II
- Regulation Number
- 870.5720
- Review Panel
- CV
- Submission Type
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.