BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biomerics NLE Access Guidewire

    Reg #: 3012159165 · FEI: 3012159165 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOMERICS Advanced Catheter
    Registration Number
    3012159165
    FEI Number
    3012159165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10351 Xylon Avenue N
    City
    Brooklyn Park
    State
    MN
    ZIP
    55445
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221390

    Owner / Operator

    Firm Name
    Biomerics
    Operator Number
    10042380
    Address
    6030 W Harold Gatty Drive
    City
    Salt Lake City
    State
    UT
    Postal Code
    84116
    Country
    US

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Biomerics NLE Access Guidewire

    Establishment Types

    Manufacture Medical Device