DeviceClearance

Product code QXV— Cardiovascular

ensoETM

Classification name
Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
Device class
Class 2
Regulation
21 CFR 870.5720
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification 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 temperature regulation to control the temperature of the esophagus during cardiac ablation.”

— U.S. Food and Drug Administration, device classification record for product code QXV under 21 CFR 870.5720, via openFDA

Market context for product code QXV

FDA has cleared 1 device under product code QXV, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXV

Recent clearances under product code QXV

Data sourced from openFDA. This site is unofficial and independent of the FDA.