FDA Registration
Inactive
🇺🇸 United States
HARBOR Occlusion Device
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NUVASCULAR INC.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 141 Innovation Dr Ste 100
- City
- Irvine
- State
- CA
- ZIP
- 92617
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250133
Owner / Operator
- Firm Name
- Nuvascular Inc.
- Operator Number
- 10091454
- Address
- 141 Innovation Drive, Suite 100
- City
- Irvine
- State
- CA
- Postal Code
- 92617
- Country
- US
- Correspondent
- Meadow S Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2025-07-10 |
Proprietary Names
HARBOR Occlusion Device
Establishment Types
Manufacture Medical Device