BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EnSite Precision™ Cardiac Mapping System, v2.1

    Reg #: 2184149 · FEI: 1000139754 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    St. Jude Medical, Atrial Fibrillation Division, Inc.
    Registration Number
    2184149
    FEI Number
    1000139754
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    One St. Jude Medical Drive
    City
    Saint Paul
    State
    MN
    ZIP
    55117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160210

    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

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    EnSite Precision™ Cardiac Mapping System, v2.1 EnSite Precision Surface Electrode Kit

    Establishment Types

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