FDA Registration
Active
🇯🇵 Japan
Aperta NSE PTA Balloon Dilatation Catheter
Reg #: 3030042169
·
FEI: 3030042169
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Goodman Co., Ltd. Aichi Facility
- Registration Number
- 3030042169
- FEI Number
- 3030042169
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1-176 Shiokusagaoka
- City
- Seto Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K243944
Owner / Operator
- Firm Name
- Goodman Co., Ltd.
- Operator Number
- 10061300
- Address
- 5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku
- City
- Nagoya
- State
- Aichi
- Postal Code
- 4600008
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2025-05-07 |
Proprietary Names
Aperta NSE PTA Balloon Dilatation Catheter
Establishment Types
Manufacture Medical Device