FDA Registration
Active
🇺🇸 United States
CentriMag Pre-connected Pack
Reg #: 2916596
·
FEI: 2916596
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- THORATEC CORP.
- Registration Number
- 2916596
- FEI Number
- 2916596
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6035 Stoneridge Dr
- City
- PLEASANTON
- State
- CA
- ZIP
- 94588
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222297
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2023-01-17 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2023-01-17 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2023-01-17 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2023-01-17 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2023-01-17 |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2023-01-17 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2023-01-17 |
Proprietary Names
CentriMag Pre-connected Pack
Establishment Types
Manufacture Medical Device