FDA Registration
Active
🇺🇸 United States
SARNS 8000 MODULAR PERFUSION SYSTEM
Reg #: 1828100
·
FEI: 1828100
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
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
- K915183
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 |
|---|---|---|---|---|---|
| Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | DTW | Class 2 | Cardiovascular | No | 2011-12-16 |
| Pump, Blood, Cardiopulmonary Bypass, Roller Type | DWB | Class 2 | Cardiovascular | No | 2011-12-16 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2011-12-16 |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2011-12-16 |
| Detector, Bubble, Cardiopulmonary Bypass | KRL | Class 2 | Cardiovascular | No | 2011-12-16 |
| Controller, Temperature, Cardiopulmonary Bypass | DWC | Class 2 | Cardiovascular | No | 2011-12-16 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2011-12-16 |
Proprietary Names
SARNS 8000 MODULAR PERFUSION SYSTEM
Establishment Types
Manufacture Medical Device