Vivio® LVEDP System— 510(k) K223905
Substantially EquivalentAvicena, LLC
FDA 510(k) clearance K223905 for Vivio® LVEDP System, Substantially Equivalent on 2023-10-06. Applicant: Avicena, LLC. Device class: 2.
Clearance details
- Applicant
- Avicena, LLC
- Product code
- Code QUO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pasadena, CA, US
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