DeviceClearance

Product code QXU— Cardiovascular

esolution

Classification name
Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
Device class
Class 2
Regulation
21 CFR 870.5710
Advisory panel
Cardiovascular
Total cleared
2
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 mechanical means to deviate the esophagus away from the source of ablation energy”

— U.S. Food and Drug Administration, device classification record for product code QXU under 21 CFR 870.5710, via openFDA

Market context for product code QXU

FDA has cleared 2 devices under product code QXU between 2023 and 2024, 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.

Clearances per year

Top applicants under product code QXU

Recent clearances under product code QXU

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