Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2916596

FEI Number

2916596

Entity Name

THORATEC CORP.

City/State/Country

PLEASANTON, CA, US

Establishment Address

6035 Stoneridge Dr, PLEASANTON, CA 94588, 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

N/A

PMA Number

P160054

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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
MOM	System, Hemodynamic, Implantable	Unknown	Class 3	N/A	2018-02-12
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2018-02-23
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Cardiovascular	Class 2	870.4100	2023-01-18
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2021-04-21
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
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2018-02-23
OJE	Right Ventricular Bypass (Assist) Device	Unknown	Class f	N/A	2018-02-23
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2018-02-16

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
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K234118	ABBOTT MEDICAL	CentriMag Acute Circulatory Support System	2024-01-26

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-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.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2916596. Last updated year: 2026. Please use registration number 2916596 when referencing this establishment in official correspondence.