FDA Registration
Active
🇯🇵 Japan
CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F
Reg #: 3000308637
·
FEI: 3000308637
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FUJI SYSTEMS CORPORATION
- Registration Number
- 3000308637
- FEI Number
- 3000308637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Shirakawa Plant, 200-2 Aza-Ohira, Odakura, Nishigo
- City
- Nishi Shirakawa Gun Fukushima
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K120781
Owner / Operator
- Firm Name
- FUJI SYSTEMS CORPORATION
- Operator Number
- 9052600
- Address
- 23-14, HONGO 3-CHOME, BUNKYO-KU, --
- City
- TOKYO
- State
- JP-13
- Postal Code
- 113-0033
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2012-08-21 |
Proprietary Names
CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F
Establishment Types
Manufacture Medical Device