FDA Registration
Active
🇺🇸 United States
Prodigy Thrombectomy System
Reg #: 3008514120
·
FEI: 3008514120
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PDV MedTech
- Registration Number
- 3008514120
- FEI Number
- 3008514120
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18655 Madrone Pkwy
- City
- Morgan Hill
- State
- CA
- ZIP
- 95037
- Country
- US
Regulatory Submissions
- 510(k) Number
- K214114
Owner / Operator
- Firm Name
- PDV MedTech
- Operator Number
- 10033287
- Address
- 18655 Madrone Parkway
- City
- Morgan Hill
- State
- CA
- Postal Code
- 95037
- Country
- US
- Correspondent
- Andrew Figueroa
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2022-12-06 |
Proprietary Names
Prodigy Thrombectomy System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)