510(k) K243233
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2024
- Date Received
- October 9, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
- Device Class
- Class II
- Regulation Number
- 870.5710
- Review Panel
- CV
- Submission Type
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