Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5710](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5710) → QXU — Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

# QXU · Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

_Cardiovascular · 21 CFR 870.5710 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QXU

## Overview

- **Product Code:** QXU
- **Device Name:** Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
- **Regulation:** [21 CFR 870.5710](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5710)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QXU/K243233.md) | esolution® Esophageal Retractor | S4 Medical Corp. | Nov 9, 2024 | SESE |
| [DEN230006](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QXU/DEN230006.md) | esolution | S4 Medical Corp. | Sep 6, 2023 | DENG |

## Top Applicants

- S4 Medical Corp. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QXU](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QXU)

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