BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM 18" Delivery System

    Reg #: 3009018440 · FEI: 3009018440 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nitinol Devices & Components Costa Rica, S. R. L.
    Registration Number
    3009018440
    FEI Number
    3009018440
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Coyol Free Zone, Building B14, B15, B25, B28
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K012056

    Owner / Operator

    Firm Name
    Confluent Medical Technologies, Inc.
    Operator Number
    10033958
    Address
    6263 N. Scottsdale Road, Suite 224
    City
    Scottsdale
    State
    AZ
    Postal Code
    85250
    Country
    US
    Correspondent
    Rich Brown

    Products

    Device Name Product Code
    Stents, Drains And Dilators For The Biliary Ducts FGE

    Proprietary Names

    PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM 18" Delivery System PALMAZ GENESIS Peripheral Stent on Slalom 18" Delivery System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)