FDA Registration
Active
🇺🇸 United States
VASSALLO GT EXT
Reg #: 1016427
·
FEI: 1016427
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cordis US Corp.
- Registration Number
- 1016427
- FEI Number
- 1016427
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 14201 N.W. 60TH AVE.
- City
- Miami Lakes
- State
- FL
- ZIP
- 33014
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222631
Owner / Operator
- Firm Name
- Cordis US Corp.
- Operator Number
- 1016427
- Address
- 5452 Betsy Ross Drive, --
- City
- Santa Clara
- State
- CA
- Postal Code
- 95054
- Country
- US
- Correspondent
- Linda Ruedy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2023-05-25 |
Proprietary Names
VASSALLO GT EXT
Establishment Types
Complaint File Establishment per 21 CFR 820.198