BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mini Trek OTW

    Reg #: 2939561 · FEI: 3004635528 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABBOTT VASCULAR
    Registration Number
    2939561
    FEI Number
    3004635528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3200 Lakeside Dr
    City
    SANTA CLARA
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123279

    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
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX

    Proprietary Names

    Mini Trek OTW Mini Trek II OTW Mini Trek RX

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility