Data / Medical devices / United States / Avicena LLC Dba Ventric Health
Avicena LLC Dba Ventric Health: FDA-registered device maker in Pasadena, CA, United States, 1 510(k) clearance
Avicena LLC Dba Ventric Health is registered with the FDA (registration 3018772859) in Pasadena, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018772859
- Address
- 117 E Colorado Blvd., Suite 510, Pasadena, CA, United States, 91105
- Owner or operator
- Avicena LLC DBA Ventric Health (10088868)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 17, 2023
- Registered through
- 2026
- Brand names listed
- Vivio System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunctive Heart Failure Status Indicator | QUO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 6, 2023 | K223905 | Vivio® LVEDP System | QUO | Substantially Equivalent | Avicena, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.