Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
The temperature regulation device for esophageal protection during cardiac ablation (product code QXV) is a Class 2 Cardiovascular device (regulation 870.5720) placed in the esophageal lumen to reduce the likelihood of esophageal injury during cardiac ablation by controlling the temperature of the esophagus during the ablation procedure. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXV
- Device Class
- FDA class 2
- Regulation Number
- 870.5720
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230021 | ensoETM | Sep 13, 2023 | Unknown | Advanced Cooling Therapy, Inc. D/B/A Attune Medical |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.