FDA Registration
Active
🇺🇸 United States
THORATEC CORP
Reg #: 1218444
·
FEI: 1218444
·
Expires 2026
Products
10
Proprietary Names
19
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- THORATEC CORP
- Registration Number
- 1218444
- FEI Number
- 1218444
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 23 4th Ave
- City
- BURLINGTON
- State
- MA
- ZIP
- 01803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222038
- PMA Number
- H070004
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 |
|---|---|---|---|---|---|
| Right Ventricular Bypass (Assist) Device | OJE | Class f | Unknown | No | 2018-02-23 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2023-01-18 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2025-09-11 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2025-09-11 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2021-04-21 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2023-01-17 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2023-01-17 |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2023-01-17 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 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 Blood Pump
CentriMag RVAS
CentriMag Blood Pump, CentriMag Acute Circulatory Support System
CentriMag Acute Circulatory Support System
2nd Generation CentriMag Primary Console and Monitor
CentriMag Circulatory Support System
HeartMate 3 LVAS
CentriMag Pre-connected Pack
CentriMag System
SQUARE OXYGENATOR BRACKET
CIRCULAR OXYGENATOR BRACKET SMALL
CIRCULAR OXYGENATOR BRACKET LARGE
CIRCULAR OXYGENATOR BRACKET MEDIUM
USB Mag Log Converter Software
CentriMag Pressure Cables
CentriMag Motor Bracket (45 Degree)
SPARE PART KIT
HeartMate II LVAS
PediMag Blood Pump
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility