FDA Registration
Active
🇺🇸 United States
THORATEC CORP.
Reg #: 2916596
·
FEI: 2916596
·
Expires 2026
Products
11
Proprietary Names
26
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- THORATEC CORP.
- Registration Number
- 2916596
- FEI Number
- 2916596
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6035 Stoneridge Dr
- City
- PLEASANTON
- State
- CA
- ZIP
- 94588
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222297
- PMA Number
- P060040
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 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2023-01-17 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 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 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2018-02-16 |
| System, Hemodynamic, Implantable | MOM | Class 3 | Unknown | No | 2018-02-12 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2023-01-18 |
| Right Ventricular Bypass (Assist) Device | OJE | Class f | Unknown | No | 2018-02-23 |
Proprietary Names
CentriMag Pre-connected Pack
HeartMate II LVAS
CentriMag System
CardioMEMS HF System
CardioMEMS Hospital Electronics System
CardioMEMS Patient Electronics System
Merlin.net Patient Care Network Heart Failure Portal
CardioMEMS PA Sensor and Delivery System
CardioMEMS Hospital System
CardioMEMS HERO Device
2nd Generation CentriMag Primary Console and Monitor
CentriMag Blood Pump, CentriMag Acute Circulatory Support System
CentriMag Blood Pump
CentriMag Circulatory Support System
CentriMag Acute Circulatory Support System
PediMag Blood Pump
CentriMag RVAS
HeartMate 3 LVAS
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
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility