FDA Registration
Active
🇺🇸 United States
Provisio SLT IVUS System
Reg #: 3016171942
·
FEI: 3016171942
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- PROVISIO MEDICAL INC.
- Registration Number
- 3016171942
- FEI Number
- 3016171942
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10815 Rancho Bernardo Rd, Suite 110
- City
- San Diego
- State
- CA
- ZIP
- 92127
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233948
Owner / Operator
- Firm Name
- Provisio Medical Inc.
- Operator Number
- 10090661
- Address
- 10815 Rancho Bernardo Rd, Suite 110
- City
- San Diego
- State
- CA
- Postal Code
- 92127
- Country
- US
- Correspondent
- Robert Ashley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-04-24 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2024-04-24 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-04-24 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-04-24 |
Proprietary Names
Provisio SLT IVUS System
Establishment Types
Manufacture Medical Device