| Device |
temperature regulation device for esophageal protection during cardiac ablation |
| 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. |
| Physical State |
A long component that allows for insertion into the esophagus and for moderating the temperature of the esophagus. The device may include a handle to allow for operator control. |
| Technical Method |
Uses a mechanism inserted into the esophagus to regulate the temperature of the esophagus. |
| Target Area |
Esophagus |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QXV |
|---|
| Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.5720
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
