Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
QXU · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5710
Classification
FDA Product Code
QXU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.5710
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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