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U.S. Department of Health and Human Services

Product Classification
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Device esophageal protection device for use in percutaneous cardiac catheter ablation procedures, mechanical deviation
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
Physical State A long component that allows for insertion into the esophagus and for movement of the esophagus. The device may include a handle to allow for operator control of deviation.
Technical Method Uses a mechanism inserted into the esophagus to move the esophagus away from the heart.
Target Area Esophagus
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQXU
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.5710
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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