BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Khelix Steerable Electrophysiology Catheter

    Reg #: 3014368660 · FEI: 3014368660 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CATHRX
    Registration Number
    3014368660
    FEI Number
    3014368660
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 8, 2-8 South St
    City
    Rydalmere New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K211327

    Owner / Operator

    Firm Name
    CathRx
    Operator Number
    10084686
    Address
    Unit 8, 2-8 South St
    City
    Rydalmere
    State
    New South Wales
    Postal Code
    2116
    Country
    AU
    Correspondent
    Jianhe Chen

    US Agent

    Business Name
    Acorn N Oakes LLC
    Contact Name
    Amy Oakes
    Address
    333 N. Dobson Rd, Suite 5 VO4
    City
    Chandler
    State
    AZ
    ZIP
    85224
    Country
    US
    Email
    [email protected]
    Phone
    480 3042165

    Products

    Device Name Product Code
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF

    Proprietary Names

    Khelix Steerable Electrophysiology Catheter Khelix Fixed Loop Steerable Electrophysiology Catheters Khelix Variable Loop Steerable Electrophysiology Catheters Khelix Loop Electrophysiology Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device