FDA Registration
Active
🇺🇸 United States
IntelliBlate Microwave Ablation System Console (IB-CON)
Reg #: 3022977243
·
FEI: 3022977243
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Varian Medical Systems, Inc.
- Registration Number
- 3022977243
- FEI Number
- 3022977243
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3550 Lexington Ave N Ste 300
- City
- Shoreview
- State
- MN
- ZIP
- 55126
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240480
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
- Correspondent
- Ali - Rezaei
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2024-07-25 |
Proprietary Names
IntelliBlate Microwave Ablation System Console (IB-CON)
IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315)
IntelliBlate Microwave Ablation System Mobile Cart (IB-CART)
IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility