Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1218444

FEI Number

1218444

Entity Name

THORATEC CORP

City/State/Country

BURLINGTON, MA, US

Establishment Address

23 4th Ave, BURLINGTON, MA 01803, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K222297

PMA Number

N/A

All Registered Proprietary Names

CentriMag Blood Pump CentriMag RVAS CentriMag Blood Pump, CentriMag Acute Circulatory Support System CentriMag Acute Circulatory Support System 2nd Generation CentriMag Primary Console and Monitor CentriMag Blood Pump CentriMag Circulatory Support System HeartMate 3 LVAS CentriMag Pre-connected Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OJE	Right Ventricular Bypass (Assist) Device	Unknown	Class f	N/A	2018-02-23
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Cardiovascular	Class 2	870.4100	2023-01-18
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2025-09-11
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Cardiovascular	Class 2	870.4100	2025-09-11
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2025-09-11
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2018-02-23
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2021-04-21
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2018-02-16
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2023-01-17
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2023-01-17
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2023-01-17
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2023-01-17
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2023-01-17
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2023-01-17
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2023-01-17

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 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K234118	ABBOTT MEDICAL	CentriMag Acute Circulatory Support System	2024-01-26
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12

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
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

Similar Registrations

Registration Number	Establishment Name	Location
3003306248	Thoratec Switzerland GMBH	ZURICH, CH
3010163695	APPLIMED SA -CSSR	Châtel St Denis Fribourg, CH
2916596	THORATEC CORP.	PLEASANTON, CA, US
9611665	Sterigenics EO Canada, Inc.	Mississauga Ontario, CA
3011468686	MC3, Inc.	Dexter, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218444. Last updated year: 2026. Please use registration number 1218444 when referencing this establishment in official correspondence.