FDA Registration
Active
🇺🇸 United States
LAVA Liquid Embolic System (LES)
Reg #: 3015355651
·
FEI: 3015355651
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BLACKSWAN VASCULAR, INC.
- Registration Number
- 3015355651
- FEI Number
- 3015355651
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 709 Sandoval Way
- City
- Hayward
- State
- CA
- ZIP
- 94544
- Country
- US
Regulatory Submissions
- PMA Number
- P220020
Owner / Operator
- Firm Name
- BlackSwan Vascular, Inc.
- Operator Number
- 10088210
- Address
- 709 Sandoval Way
- City
- Hayward
- State
- CA
- Postal Code
- 94544
- Country
- US
- Correspondent
- Jeffrey Cyr
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Embolization Agent, Vascular | QVG | Class 3 | Unknown | No | 2023-06-09 |
Proprietary Names
LAVA Liquid Embolic System (LES)
LAVA Mixing Kit
LAVA Liquid Embolic System (LES) Kit.
Establishment Types
Manufacture Medical Device