BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    KARDIUM Inc.

    Reg #: 3007603855 · FEI: 3007603855 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    KARDIUM Inc.
    Registration Number
    3007603855
    FEI Number
    3007603855
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8518 Glenlyon Parkway, Unit 155
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K250529
    PMA Number
    P240044

    Owner / Operator

    Firm Name
    Kardium Inc.
    Operator Number
    10028366
    Address
    8518 Glenlyon Parkway, Unit 155
    City
    Burnaby
    State
    British Columbia
    Postal Code
    V5J0B6
    Country
    CA
    Correspondent
    Ricardo Romero

    US Agent

    Business Name
    Kardium US Inc.
    Contact Name
    Doug Goertzen
    Address
    5775 Wayzata Blvd Ste 700-4048
    City
    St Louis Park
    State
    MN
    ZIP
    55416
    Country
    US
    Email
    [email protected]
    Phone
    256 9078330

    Products

    Device Name Product Code
    Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA
    Twister, Wire HXS
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Catheter, Steerable DRA
    Computer, Diagnostic, Programmable DQK
    Introducer, Catheter DYB
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    Globe® Platform Globe® Catheter Cable Support TORQ Globe® Catheter Globe® Pulsed Field System Globe® Introducer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility