FEI 3020256033
Innova Vascular, Inc.
15375 Barranca Parkway, B-101, Irvine, CA, US
MDR events0All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3020256033.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jan 12, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jan 12, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Jan 12, 2026
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.80(d)Jan 12, 2026
Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Jan 12, 2026
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.