DEN230021 is an FDA 510(k) submission for the ensoETM. This device is classified as a Temperature Regulation Device For Esophageal Protection During Cardiac Ablation (Class II - Special Controls, product code QXV).
Submitted by Advanced Cooling Therapy, Inc. D/B/A Attune Medical (Chicago, US). The FDA issued a Not Cleared (DENG) decision on September 13, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5720. 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 Temperature Regulation To Control The Temperature Of The Esophagus During Cardiac Ablation..
| 510(k) Number | DEN230021 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 30, 2023 |
| Decision Date | September 13, 2023 |
| Days to Decision | 167 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QXV - Temperature Regulation Device For Esophageal Protection During Cardiac Ablation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5720 |
| 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 Temperature Regulation To Control The Temperature Of The Esophagus During Cardiac Ablation. |