BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CATHWORKS

    Reg #: 3015192387 · FEI: 3015192387 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    CATHWORKS
    Registration Number
    3015192387
    FEI Number
    3015192387
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4000 MacArthur Blvd, Suite 1025 - East Tower
    City
    Newport Beach
    State
    CA
    ZIP
    92660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192442

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Angiographic Coronary Vascular Physiologic Simulation Software QEK

    Proprietary Names

    FFRangio™ FFRangio™ System

    Establishment Types

    Manufacture Medical Device