BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLEX Vessel Prep™ System

    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
    K202187

    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
    Catheter, Percutaneous, Cutting/Scoring PNO

    Proprietary Names

    FLEX Vessel Prep™ System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)