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    FDA Registration Active 🇺🇸 United States

    Agilis HisPro Steerable Catheter With Electrodes Model DS3H010-38

    Reg #: 2182269 · FEI: 2182269 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    St. Jude Medical, Atrial Fibrillation Division, Inc.
    Registration Number
    2182269
    FEI Number
    2182269
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14901 DEVEAU PL.
    City
    Minnetonka
    State
    MN
    ZIP
    55345
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200721

    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
    Catheter, Percutaneous DQY
    Catheter, Steerable DRA

    Proprietary Names

    Agilis HisPro Steerable Catheter With Electrodes Model DS3H010-38

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)