Data / Medical devices / United States / Thoratec Corp
Thoratec Corp: FDA-registered device maker in Burlington, MA, United States, 6 510(k) clearances and 3 PMA approvals
Thoratec Corp is registered with the FDA (registration 1218444) in Burlington, MA, United States. It lists 10 device types. The FDA files 6 510(k) clearances and 3 PMA approvals under its listings, the newest dated January 26, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1218444
- Address
- 23 4th Ave, Burlington, MA, United States, 01803
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 16, 2018
- Registered through
- 2027
- Brand names listed
- 2nd Generation CentriMag Primary Console and Monitor, CIRCULAR OXYGENATOR BRACKET LARGE, CIRCULAR OXYGENATOR BRACKET MEDIUM, CIRCULAR OXYGENATOR BRACKET SMALL, CentriMag Blood Pump, CentriMag Blood Pump, CentriMag Acute Circulatory Support System, CentriMag Circulatory Support System, CentriMag Motor Bracket (45 Degree) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Complaint file establishment | accessdata.fda.gov |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Complaint file establishment | accessdata.fda.gov |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | 2 | Complaint file establishment | accessdata.fda.gov |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Complaint file establishment | accessdata.fda.gov |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 2 | Complaint file establishment | accessdata.fda.gov |
| Oxygenator, Cardiopulmonary Bypass | DTZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | 2 | Complaint file establishment | accessdata.fda.gov |
| Right Ventricular Bypass (Assist) Device | OJE | f | Complaint file establishment | accessdata.fda.gov |
| Ventricular (Assist) Bypass | DSQ | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 26, 2024 | K234118 | CentriMag Acute Circulatory Support System | QNR | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 8, 2022 | K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System | QNR | Substantially Equivalent | Abbott (Formerly Thoratec Corporation) | accessdata.fda.gov |
| December 1, 2022 | K222297 | CentriMag Pre-connected Pack | DTZ | Substantially Equivalent | Abbott | accessdata.fda.gov |
| August 27, 2010 | K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | DWA | Substantially Equivalent | Levitronix, LLC | accessdata.fda.gov |
| October 8, 2009 | K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 | KFM | Substantially Equivalent | Levitronix, LLC | accessdata.fda.gov |
| March 25, 2003 | K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 | KFM | Substantially Equivalent | Levitronix, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 6, 2019 | P170038 | CentriMag Circulatory Support System | DSQ | 32 | October 2, 2026 | accessdata.fda.gov |
| August 23, 2017 | P160054 | HeartMate 3 Left Ventricular Assist System | DSQ | 132 | October 19, 2026 | accessdata.fda.gov |
| April 21, 2008 | P060040 | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM | DSQ | 125 | October 1, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Ventricular (Assist) Bypass
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- All makers of Heat-Exchanger, Cardiopulmonary Bypass
Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.