Thoratec Switzerland GMBH

FDA Device Registration & Listing · ZURICH, CH · Registration 3003306248

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003306248
FEI Number
3003306248
Entity Name
Thoratec Switzerland GMBH
City/State/Country
ZURICH, CH
Establishment Address
TECHNOPARKSTRASSE 1, ZURICH CH-8005, CH
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
N
Expiration Date (Year)
2026
510(k) Number
K090051
PMA Number
N/A

All Registered Proprietary Names

CentriMag Blood Pump CentriMag RVAS CentriMag System CentriMag Blood Pump CentriMag Circulatory Support System SQUARE OXYGENATOR BRACKET CIRCULAR OXYGENATOR BRACKET SMALL CIRCULAR OXYGENATOR BRACKET LARGE CIRCULAR OXYGENATOR BRACKET MEDIUM USB Mag Log Converter Software CentriMag Pressure Cables CentriMag Motor Bracket (45 Degree) SPARE PART KIT CentriMag™ Acute Circulatory Support System 2nd Generation CentriMag Primary Console and Monitor CentriMag Blood Pump, CentriMag Acute Circulatory Support System PediMag Blood Pump

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
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 2021-04-21
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2019-09-20
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
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 2018-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

Lucy Tan Business: ABBOTT LABORATORIES Email: lucy.tan@abbott.com Phone: (925) 4169778

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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003306248. Last updated year: 2026. Please use registration number 3003306248 when referencing this establishment in official correspondence.
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