FDA Registration
Active
🇺🇸 United States
Truvic Medical Inc. Prodigy Thrombectomy System
Reg #: 3014590708
·
FEI: 3014590708
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- IMPERATIVE CARE INC.
- Registration Number
- 3014590708
- FEI Number
- 3014590708
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1359 Dell Ave
- City
- Campbell
- State
- CA
- ZIP
- 95008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K214114
Owner / Operator
- Firm Name
- Imperative Care Inc.
- Operator Number
- 10058493
- Address
- 1359 Dell Ave
- City
- Campbell
- State
- CA
- Postal Code
- 95008
- Country
- US
- Correspondent
- Michael Wong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2023-12-13 |
Proprietary Names
Truvic Medical Inc. Prodigy Thrombectomy System
Imperative Care, Inc. Prodigy Thrombectomy System
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility