FDA Registration
Active
🇨🇳 China
KDL Micro Catheter, INT® Micro Catheter
Reg #: 3009605245
·
FEI: 3009605245
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Shanghai INT Medical Instruments Co., Ltd.
- Registration Number
- 3009605245
- FEI Number
- 3009605245
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 925 Jinyuan Yi Road
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201706
Owner / Operator
- Firm Name
- Shanghai INT Medical Instruments Co., Ltd.
- Operator Number
- 10051494
- Address
- 925 Jinyuan Yi Road
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201803
- Country
- CN
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Rd
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-07-27 |
Proprietary Names
KDL Micro Catheter, INT® Micro Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device