FDA Registration
Active
🇺🇸 United States
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
Reg #: 3008627763
·
FEI: 3008627763
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- I-Tek Medical, Inc.
- Registration Number
- 3008627763
- FEI Number
- 3008627763
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1837 Buerkle Rd
- City
- White Bear Lake
- State
- MN
- ZIP
- 55110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071029
Owner / Operator
- Firm Name
- I-Tek Medical, Inc.
- Operator Number
- 10047604
- Address
- 1837 Buerkle Road
- City
- White Bear Lake
- State
- MN
- Postal Code
- 55110
- Country
- US
- Correspondent
- Patrick Haley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2014-10-10 |
Proprietary Names
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)