FDA Registration
Active
🇯🇵 Japan
NIPRO VASCULAR CORPORATION
Reg #: 3007835716
·
FEI: 3007835716
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- NIPRO VASCULAR CORPORATION
- Registration Number
- 3007835716
- FEI Number
- 3007835716
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku
- City
- Nagoya Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K243944
Owner / Operator
- Firm Name
- NIPRO VASCULAR CORPORATION
- Operator Number
- 10061300
- Address
- 5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku
- City
- Nagoya
- State
- Aichi
- Postal Code
- 4600008
- Country
- JP
- Correspondent
- Hirotaka Ishii
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2021-02-12 |
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2025-05-07 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2019-10-07 |
Proprietary Names
GM-30 Inflation Device
Aperta NSE PTA Balloon Dilatation Catheter
OKAYII Y-Connector Set
Establishment Types
Manufacture Medical Device