Contract manufacturerContract sterilizerLivaNova USA, INC. (Arvada, CO)ColoradoCardiovascularClass II
LivaNova USA, INC.
Contract manufacturer and sterilizer · Arvada, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1718850 (openFDA record; or search FDA's registration database)
- FEI number
- 1718850
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler; Contract sterilizer
- Owner or operator
- LivaNova (FDA owner/operator no. 9003795)
- Registered address
- 14401 WEST 65TH WAY, Arvada, CO 80004
- Contract listings
- 22 device listings, 3 product codes, first listed Nov 6, 2014
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | Cardiovascular | Contract manufacturing | Jul 10, 2024 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | Cardiovascular | Contract sterilization | Jul 10, 2024 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Nov 6, 2014 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract sterilization | Nov 6, 2014 |
| PZS | Dual Lumen Ecmo Cannula | Class II | Cardiovascular | Contract manufacturing | Jul 10, 2024 |
| PZS | Dual Lumen Ecmo Cannula | Class II | Cardiovascular | Contract sterilization | Jul 10, 2024 |