FDA Registration
Active
🇺🇸 United States
Starlight Imaging Catheter
Reg #: 3017654247
·
FEI: 3017654247
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SPECTRAWAVE, INC.
- Registration Number
- 3017654247
- FEI Number
- 3017654247
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12 Oak Park Drive
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221257
Owner / Operator
- Firm Name
- SpectraWAVE, Inc.
- Operator Number
- 10084575
- Address
- 12 Oak Park Drive
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Optical Coherence Tomography, Intravascular Catheter | ORD | Class 2 | Cardiovascular | No | 2023-03-24 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2023-03-24 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2023-03-24 |
| Catheter, Intravascular, Plaque Morphology Evaluation | OGZ | Class 2 | Cardiovascular | No | 2023-03-24 |
Proprietary Names
Starlight Imaging Catheter
HyperVue Imaging System
Establishment Types
Manufacture Medical Device