QXVClass II
Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
21 CFR 870.5720 / Cardiovascular
QXV is the FDA product code for Temperature Regulation Device For Esophageal Protection During Cardiac Ablation, a class II device type, regulated under 21 CFR 870.5720. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QXV
- Device name
- Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
- FDA 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.
- Regulation
- 21 CFR 870.5720
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QXV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QXV| Applicant | Clearances |
|---|---|
| Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.