QXU · Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
Cardiovascular · 21 CFR 870.5710 · Class 2
Overview
| Product Code | QXU |
|---|---|
| Device Name | Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation |
| Regulation | 21 CFR 870.5710 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
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
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243233 | esolution® Esophageal Retractor | S4 Medical Corp. | Nov 9, 2024 | SESE |
| DEN230006 | esolution | S4 Medical Corp. | Sep 6, 2023 | DENG |
Top Applicants
- S4 Medical Corp. — 2 clearances
