FDA Registration
Active
🇺🇸 United States
Blade
Reg #: 1828100
·
FEI: 1828100
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Registration Number
- 1828100
- FEI Number
- 1828100
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6200 Jackson Road
- City
- ANN ARBOR
- State
- MI
- ZIP
- 48103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K935391
Owner / Operator
- Firm Name
- Terumo Cardiovascular Systems Corp.
- Operator Number
- 10039199
- Address
- 6200 Jackson Road
- City
- Ann Arbor
- State
- MI
- Postal Code
- 48103
- Country
- US
- Correspondent
- Lisa Hessabi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2011-12-16 |
Proprietary Names
Blade
Establishment Types
Manufacture Medical Device