Skip to contentDe Novo DEN250012
- Device
- LifeVac
- Contact
- arthur lih
- De Novo number
- DEN250012
- Product code
- QXN
- Regulation
- 874.5400
- Classification name
- suction anti-choking device as a second-line treatment
- Decision
- granted (DENG)
- Decision date
- 2026-03-04
- Date received
- 2025-04-11
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- QXN
- Device name
- Suction Anti-Choking Device As A Second-Line Treatment
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.5400
- Implant
- N
- Life sustain/support
- Y