QXV — Temperature Regulation Device For Esophageal Protection During Cardiac Ablation Class II
FDA product code QXV covers "Temperature Regulation Device For Esophageal Protection During Cardiac Ablation", a Class II medical device regulated under 21 CFR 870.5720. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXV
- Device Class
- Class II
- Regulation Number
- 870.5720
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230021 | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | ensoETM | Sep 13, 2023 |