BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Agilis™ NxT Steerable Introducer Dual-Reach™, Steerable Introducer

    Reg #: 3008452825 · FEI: 3008452825 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Medical Costa Rica Ltda.
    Registration Number
    3008452825
    FEI Number
    3008452825
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K241370

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Agilis™ NxT Steerable Introducer Dual-Reach™, Steerable Introducer Agilis™ NxT Steerable Introducer

    Establishment Types

    Manufacture Medical Device