BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Thoratec Switzerland GMBH

    Reg #: 3003306248 · FEI: 3003306248 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    Thoratec Switzerland GMBH
    Registration Number
    3003306248
    FEI Number
    3003306248
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    TECHNOPARKSTRASSE 1
    City
    ZURICH
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K020271
    PMA Number
    H070004

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    ABBOTT LABORATORIES
    Contact Name
    Lucy Tan
    Address
    6035 Stoneridge Drive
    City
    Pleasanton
    State
    CA
    ZIP
    94588
    Country
    US
    Email
    [email protected]
    Phone
    925 4169778

    Products

    Device Name Product Code
    Right Ventricular Bypass (Assist) Device OJE
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Ventricular (Assist) Bypass DSQ
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Blood Pump For Ecmo, Long-Term (> 6 Hours) Use QNR
    Control, Pump Speed, Cardiopulmonary Bypass DWA

    Proprietary Names

    CentriMag Blood Pump CentriMag RVAS CentriMag System 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

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility