21 CFR 870.5720 — Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5720
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXV | Temperature Regulation Device For Esophageal Protection During Cardiac Ablation | 2 | 1 |
Special Controls
QXV — Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
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:
De Novo Order DEN230021
