FDA Registration
Active
🇺🇸 United States
Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42)
Reg #: 3015551113
·
FEI: 3015551113
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- INFRAREDX, INC.
- Registration Number
- 3015551113
- FEI Number
- 3015551113
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 28 Crosby Drive, Suite 100
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241576
Owner / Operator
- Firm Name
- Infraredx, Inc.
- Operator Number
- 10025766
- Address
- 28 Crosby Drive, Suite 100
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- Nozomi Yagi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-03-26 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-03-26 |
| Catheter, Intravascular, Plaque Morphology Evaluation | OGZ | Class 2 | Cardiovascular | No | 2025-03-26 |
Proprietary Names
Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42)
Makoto Intravascular Imaging System (TVC-MC10/TVC-MC10i)
Clarispro HD-IVUS Imaging Catheter (TVC-E195-42)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198