FDA Registration
Active
🇯🇵 Japan
07-935-52 Sugita AVM Microclip II Single Shaft Applier 90 mm, Str, w/o Catches
Reg #: 9680242
·
FEI: 3009504761
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIZUHO Corporation Gosen Factory
- Registration Number
- 9680242
- FEI Number
- 3009504761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3631-14, Akomi
- City
- Gosen Niigata
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K221524
Owner / Operator
- Firm Name
- MIZUHO Corporation
- Operator Number
- 9007414
- Address
- 3-30-13 HONGO
- City
- BUNKYO-KU
- State
- Tokyo
- Postal Code
- 1130033
- Country
- JP
US Agent
- Business Name
- MIZUHO AMERICA, INC.
- Contact Name
- RICHARD CHADWICK
- Address
- 30057 AHERN AVENUE
- City
- Union City
- State
- CA
- ZIP
- 94587
- Country
- US
- [email protected]
- Phone
- 510 3244500 ext. 150
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applier, Aneurysm Clip | HCI | Class 2 | Neurology | No | 2023-12-17 |
Proprietary Names
07-935-52 Sugita AVM Microclip II Single Shaft Applier 90 mm, Str, w/o Catches
07-935-57 Sugita AVM Microclip II Single Shaft Applier 150 mm, 30 deg, w/o Catches
07-935-55 Sugita AVM Microclip II Single Shaft Applier 110 mm, 30 deg, w/o Catches
07-935-54 Sugita AVM Microclip II Single Shaft Applier 110 mm, Str, w/o Catches
07-935-53 Sugita AVM Microclip II Single Shaft Applier 90 mm, 30 deg, w/o Catches
07-935-31 Sugita AVM Microclip II Applier 50 mm
07-935-30 Sugita AVM Microclip II Applier 100 mm
07-935-56 Sugita AVM Microclip II Single Shaft Applier 150 mm, Str, w/o Catches
Establishment Types
Manufacture Medical Device