BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dragonfly OpStar™ Imaging Catheter.

    Reg #: 3009600098 · FEI: 3009600098 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3009600098
    FEI Number
    3009600098
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Robbins Rd
    City
    Westford
    State
    MA
    ZIP
    01886
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230411

    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, Intravascular, Diagnostic DQO

    Proprietary Names

    Dragonfly OpStar™ Imaging Catheter.

    Establishment Types

    Manufacture Medical Device