FDA Registration
Active
🇺🇸 United States
Thoratec Corporation
Reg #: 3008792657
·
FEI: 3008792657
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- Thoratec Corporation
- Registration Number
- 3008792657
- FEI Number
- 3008792657
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4550 Norris Canyon Rd
- City
- San Ramon
- State
- CA
- ZIP
- 94583
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020271
- 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 |
|---|---|---|---|---|---|
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2018-02-16 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2018-02-23 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2018-02-23 |
| System, Hemodynamic, Implantable | MOM | Class 3 | Unknown | No | 2018-02-12 |
| Right Ventricular Bypass (Assist) Device | OJE | Class f | Unknown | No | 2018-02-23 |
Proprietary Names
HeartMate II LVAS
CentriMag System
HeartMate 3 LVAS
2nd Generation CentriMag Primary Console and Monitor
CentriMag Blood Pump
CentriMag Circulatory Support 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
CentriMag RVAS
Establishment Types
Manufacture Medical Device