LifeVac
FDA 510(k) clearance DEN250012 · decided 2026-03-04
Clearance details
- K-number
- DEN250012
- Device name
- LifeVac
- Applicant
- Lifevac, LLC
- Decision
- Unknown
- Date received
- 2025-04-11
- Decision date
- 2026-03-04
- Days to decision
- 327 days
- Clearance type
- Direct
- Product code
- QXN
- Device class
- 2
- Regulation number
- 874.5400
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Nesconset, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.