BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iMap 3d Mapping and Navigation System

    Reg #: 3020036682 · FEI: 3020036682 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CARDIONXT
    Registration Number
    3020036682
    FEI Number
    3020036682
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12011 N Tejon St Suite 700
    City
    Westminster
    State
    CO
    ZIP
    80234
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201094

    Owner / Operator

    Firm Name
    CardioNXT
    Operator Number
    10050640
    Address
    12011 N Tejon St Suite 700
    City
    Westminster
    State
    CO
    Postal Code
    80234
    Country
    US
    Correspondent
    Keith Martin

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    iMap 3d Mapping and Navigation System Axis Patient Patches MultiLink CS Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device