BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FreedomFlow Orbital Circumferential Atherectomy System

    Reg #: 3015124694 · FEI: 3015124694 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIO FLOW, INC.
    Registration Number
    3015124694
    FEI Number
    3015124694
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3530 88th Ave NE
    City
    Blaine
    State
    MN
    ZIP
    55014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231538

    Owner / Operator

    Firm Name
    Cardio Flow, Inc.
    Operator Number
    10084699
    Address
    3530 88th Ave NE
    City
    Blaine
    State
    MN
    Postal Code
    55014
    Country
    US
    Correspondent
    Michael Kallok

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    FreedomFlow Orbital Circumferential Atherectomy System FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility