FDA Registration
Active
🇺🇸 United States
SurVeil Drug-Coated Balloon
Reg #: 3001374820
·
FEI: 3001374820
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SURMODICS, INC.
- Registration Number
- 3001374820
- FEI Number
- 3001374820
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9924 W 74th St
- City
- EDEN PRAIRIE
- State
- MN
- ZIP
- 55344
- Country
- US
Regulatory Submissions
- PMA Number
- P210025
Owner / Operator
- Firm Name
- SURMODICS, INC.
- Operator Number
- 9070604
- Address
- 9924 WEST 74TH STREET, --
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
- Correspondent
- SHAWN K FULLER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | Class 3 | Unknown | No | 2023-08-09 |
Proprietary Names
SurVeil Drug-Coated Balloon
Establishment Types
Manufacture Medical Device