Data / Medical devices / United States / Thoratec Corporation

Thoratec Corporation: FDA-registered device maker in San Ramon, CA, United States, 2 510(k) clearances and 4 PMA approvals

Name: Thoratec Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Thoratec Corporation is registered with the FDA (registration 3008792657) in San Ramon, CA, United States. It lists 5 device types. The FDA files 2 510(k) clearances and 4 PMA approvals under its listings, the newest dated December 6, 2019. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008792657
Address: 4550 Norris Canyon Rd, San Ramon, CA, United States, 94583
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer
First device listed: February 12, 2018
Registered through: 2027
Brand names listed: 2nd Generation CentriMag Primary Console and Monitor, CardioMEMS HERO Device, CardioMEMS HF System, CardioMEMS Hospital Electronics System, CardioMEMS Hospital System, CardioMEMS PA Sensor and Delivery System, CardioMEMS Patient Electronics System, CentriMag Blood Pump and more

Devices it lists

Device	Product code	Class	Role	Source
Control, Pump Speed, Cardiopulmonary Bypass	DWA	2	Manufacturer	accessdata.fda.gov
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	KFM	2	Manufacturer	accessdata.fda.gov
Right Ventricular Bypass (Assist) Device	OJE	f	Manufacturer	accessdata.fda.gov
System, Hemodynamic, Implantable	MOM	3	Manufacturer	accessdata.fda.gov
Ventricular (Assist) Bypass	DSQ	3	Manufacturer	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
August 27, 2010	K102129	LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR	DWA	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
May 28, 2014	P100045	CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM	MOM	90	September 30, 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

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.