Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008792657

FEI Number

3008792657

Entity Name

Thoratec Corporation

City/State/Country

San Ramon, CA, US

Establishment Address

4550 Norris Canyon Rd, San Ramon, CA 94583, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102129

PMA Number

N/A

All Registered Proprietary Names

HeartMate II LVAS CentriMag System HeartMate 3 LVAS 2nd Generation CentriMag Primary Console and Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2018-02-16
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2018-02-23
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2018-02-16
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2018-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2007	Thoratec Corp	3	Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Z-0005-2017	Heartware, Inc.	3	HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Z-0006-2017	HeartWare, Inc	3	HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Z-0015-2007	Thoratec Corp	3	Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

Similar Registrations

Registration Number	Establishment Name	Location
3008454189	BERLIN HEART, INC.	The Woodlands, TX, US
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
2916596	THORATEC CORP.	PLEASANTON, CA, US
2134470	LOWELL,INC.	Brooklyn Park, MN, US
3012931014	INVENTUS POWER	Woodridge, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008792657. Last updated year: 2026. Please use registration number 3008792657 when referencing this establishment in official correspondence.