DEN250012
- 510(k) number
- DEN250012
- Device name
- LifeVac
- Applicant
- Lifevac, LLC NY · US
- Product code
- QXN — Suction Anti-Choking Device As A Second-Line Treatme
- Decision date
- 2026-03-04
- Date received
- 2025-04-11
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ear, Nose, Throat
Official FDA record: DEN250012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.