De Novo DEN230021
- Device
- ensoETM
- Contact
- erik kulstad
- De Novo number
- DEN230021
- Product code
- QXV
- Regulation
- 870.5720
- Classification name
- temperature regulation device for esophageal protection during cardiac ablation
- Decision
- granted (DENG)
- Decision date
- 2023-09-13
- Date received
- 2023-03-30
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QXV
- Device name
- Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.5720
- Implant
- N
- Life sustain/support
- N