510(k) DEN230021
DEN230021 is an FDA 510(k) premarket notification submitted by Advanced Cooling Therapy, Inc. D/B/A Attune Medical for the device "ensoETM". The FDA issued a decision of De Novo Granted on Sep 13, 2023. The device falls under product code QXV (Temperature Regulation Device For Esophageal Protection During Cardiac Ablation), a Class II device regulated under 21 CFR 870.5720. Advanced Cooling Therapy, Inc. D/B/A Attune Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Sep 13, 2023
- Date Received
- Mar 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.