510(k) DEN230006
DEN230006 is an FDA 510(k) premarket notification submitted by S4 Medical Corp. for the device "esolution". The FDA issued a decision of De Novo Granted on September 6, 2023. The device falls under product code QXU (Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation), a Class II device regulated under 21 CFR 870.5710. S4 Medical Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 6, 2023
- Date Received
- January 24, 2023
- Clearance Type
- Direct
- 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