Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5720](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5720) → QXV — Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

# QXV · Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

_Cardiovascular · 21 CFR 870.5720 · Class 2_

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

## Overview

- **Product Code:** QXV
- **Device Name:** Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
- **Regulation:** [21 CFR 870.5720](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5720)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

The ensoETM is a multi-lumen silicone tube placed in the esophagus to connect to an external heat exchanger to either cool or warm a patient or to cool the esophagus to reduce the likelihood of thermal injury after radiofrequency (RF) cardiac ablation procedures. It also provides gastric decompression and suctioning.

## Classification Rationale

Class II (special controls). The device is a temperature regulation device for esophageal protection during cardiac ablation procedures, and the FDA has determined that the benefits outweigh the risks when mitigated by the use of class II controls.

## Special Controls

In combination with the general controls of the FD&C Act, the temperature regulation device for esophageal protection during cardiac ablation procedures device is subject to the following special controls:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230021](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QXV/DEN230021.md) | ensoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | Sep 13, 2023 | DENG |

## Top Applicants

- Advanced Cooling Therapy, Inc. D/B/A Attune Medical — 1 clearance

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

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