De Novo DEN230006
- Device
- esolution
- Contact
- william fuller
- De Novo number
- DEN230006
- Product code
- QXU
- Regulation
- 870.5710
- Classification name
- esophageal protection device for use in percutaneous cardiac catheter ablation procedures, mechanical deviation
- Decision
- granted (DENG)
- Decision date
- 2023-09-06
- Date received
- 2023-01-24
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QXU
- Device name
- Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.5710
- Implant
- N
- Life sustain/support
- N