BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

    K Number: K211327 · Decision Feb 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    1
    Review Days
    283

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    Basic Information

    Device Name
    Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
    K Number
    K211327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CathRx, Ltd.
    Date Received
    May 3, 2021
    Decision Date
    February 10, 2022
    Product Code
    DRF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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