FDA Registration
Active
🇯🇵 Japan
Terumo PriorityOne AC
Reg #: 3009500972
·
FEI: 3009500972
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TERUMO CLINICAL SUPPLY CO., LTD.
- Registration Number
- 3009500972
- FEI Number
- 3009500972
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3 Kawashima-Takehaya-machi,
- City
- Kakamigahara Gifu
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K112382
Owner / Operator
- Firm Name
- Terumo Clinical Supply Co., Ltd.
- Operator Number
- 10039657
- Address
- 3 Kawashima-Takehaya-machi,
- City
- Kakamigahara,Gifu
- State
- JP-NOTA
- Postal Code
- 501-6024
- Country
- JP
US Agent
- Business Name
- TERUMO Medical Corp
- Contact Name
- Dina Justice
- Address
- 950 Elkton Blvd.
- City
- Elkton
- State
- MD
- ZIP
- 21921
- Country
- US
- [email protected]
- Phone
- 410 3927226
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2012-01-31 |
Proprietary Names
Terumo PriorityOne AC
Establishment Types
Manufacture Medical Device