FDA Registration
Active
🇺🇸 United States
Ruby XL System
Reg #: 3005168196
·
FEI: 3005168196
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PENUMBRA, INC.
- Registration Number
- 3005168196
- FEI Number
- 3005168196
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- One Penumbra Place
- City
- Alameda
- State
- CA
- ZIP
- 94502
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250079
Owner / Operator
- Firm Name
- PENUMBRA, INC.
- Operator Number
- 9072336
- Address
- One Penumbra Place
- City
- Alameda
- State
- CA
- Postal Code
- 94502
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2025-03-21 |
Proprietary Names
Ruby XL System
Establishment Types
Manufacture Medical Device