Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
QXU is the FDA product code for Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation, a class II device type, regulated under 21 CFR 870.5710. 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 mechanical means to deviate the esophagus away from the source of ablation energy". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QXU
- Device name
- Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
- 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 mechanical means to deviate the esophagus away from the source of ablation energy
- Regulation
- 21 CFR 870.5710
- 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
- 2
- Ingested recalls
- 0
Clearances, product code QXU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code QXU| Applicant | Clearances |
|---|---|
| S4 Medical Corp | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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