510(k) K223905
- Device
- Vivio® LVEDP System
- Applicant
- Avicena, LLC
- 510(k) number
- K223905
- Product code
- QUO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-06
- Date received
- 2022-12-28
- Regulation
- 870.2200
- Classification name
- Adjunctive Heart Failure Status Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sean Brady
- Address
- 117 E. Colorado Blvd., Suite 510 Pasadena CA US 91105 91105
FDA Registration Numbers#
- 2951215
- 3018772859
- 3016585383