BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Arcadia Balloon Catheter Kit

    Reg #: 3012536737 · FEI: 3012536737 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Merit Medical Canada Ltd.
    Registration Number
    3012536737
    FEI Number
    3012536737
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Valleywood Drive, units 4&5
    City
    Markham Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K191596

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    MERIT MEDICAL SYSTEMS, INC.
    Contact Name
    John Knorpp
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Tamp HXG
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    Arcadia Balloon Catheter Kit Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device