FDA Registration
Active
🇺🇸 United States
Freestyle Obturators
Reg #: 2025587
·
FEI: 2025587
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Medtronic Heart Valves Division
- Registration Number
- 2025587
- FEI Number
- 2025587
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1851 EAST DEERE AVE.
- City
- Santa Ana
- State
- CA
- ZIP
- 92705
- Country
- US
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 1992-07-30 |
Proprietary Names
Freestyle Obturators
Duran Ancore Sizers
Simulus Sizers
Mosaic Aortic and Mitral Obturators
Avalus Sizers
Open Pivot sizers
Hancock II ULTRA Supra-X Aortic Sizers
Mosaic Ultra Supra-X Aortic Sizers
CG Future Sizers
Profile 3D Ring Sizers
TriAd sizers
Hancock II Aortic and Mitral Obturators
Contour 3D sizers
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device