BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Medtronic CryoCath LP

    Reg #: 3002648230 · FEI: 3002648230 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Medtronic CryoCath LP
    Registration Number
    3002648230
    FEI Number
    3002648230
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9000 Autoroute Transcanadienne
    City
    Pointe-Claire Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K183174
    PMA Number
    P230017

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    MEDTRONIC, INC.
    Contact Name
    Rashmi Bhushan
    Address
    8200 Coral Sea St NE, MVS33
    City
    Mounds View
    State
    MN
    ZIP
    55112
    Country
    US
    Email
    [email protected]
    Phone
    763 6070535

    Products

    Device Name Product Code
    Catheter, Steerable DRA
    Introducer, Catheter DYB
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Cardiac Ablation Percutaneous Catheter LPB

    Proprietary Names

    FlexCath Advance FlexCath Select PulseSelect™ Pulsed Field Ablation (PFA) Freezor MAX Freezor cardiac cryoablation catheter Freezor MAX Surgical cryoablation catheter Freezor Xtra Surgical cardiac cryoablation catheter Cryoconsole Freezor Xtra cardiac cryoablation catheter ECG Cable Coaxial Cable Nitron Remote Nitron CryoConsole Freezor Freezor Xtra Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM Pulse Select Sphere 360 FlexCath Advance Steerable Sheath and Dilator

    Establishment Types

    Manufacture Medical Device