FDA Registration
Active
🇺🇸 United States
Embozene Color-Advanced Microspheres
Reg #: 3008262715
·
FEI: 3008262715
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Varian Medical Systems, Inc
- Registration Number
- 3008262715
- FEI Number
- 3008262715
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9825 Spectrum Drive, Building 2
- City
- Austin
- State
- TX
- ZIP
- 78717
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180102
Owner / Operator
- Firm Name
- Varian Medical Systems, Inc
- Operator Number
- 2914292
- Address
- 3100 Hansen Way, --
- City
- Palo Alto
- State
- CA
- Postal Code
- 94304
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2022-11-02 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2022-11-02 |
| Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | NOY | Class 2 | Gastroenterology, Urology | No | 2022-11-02 |
Proprietary Names
Embozene Color-Advanced Microspheres
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device