DEN230006 is an FDA 510(k) submission for the esolution. This device is classified as a Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation (Class II - Special Controls, product code QXU).
Submitted by S4 Medical Corp. (Chagrin Falls, US). The FDA issued a Not Cleared (DENG) decision on September 6, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5710. 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.
| 510(k) Number | DEN230006 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 24, 2023 |
| Decision Date | September 06, 2023 |
| Days to Decision | 225 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QXU - Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5710 |
| 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 |