BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Oasis-One Action Stent Introduction system(R)

    Reg #: 3005580113 · FEI: 3005580113 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COOK MEDICAL LLC
    Registration Number
    3005580113
    FEI Number
    3005580113
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    400 DANIELS WAY
    City
    Bloomington
    State
    IN
    ZIP
    47404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K851962

    Owner / Operator

    Firm Name
    COOK MEDICAL
    Operator Number
    9090900
    Address
    400 DANIELS WAY, --
    City
    Bloomington
    State
    IN
    Postal Code
    47404
    Country
    US
    Correspondent
    Ed - Sutkowski

    Products

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

    Proprietary Names

    Oasis-One Action Stent Introduction system(R) Oasis® One Action Stent Introduction System with Pre-Loaded ST-2 Tannenbaum® Biliary Stent Oasis-one action stent introduction system® with Pre-loaded Cotton-Leung® Biliary Stent Solus Biliary Stent and Introducer Set Solus(R) Double Pigtail Stent with Introducer Huibregtse Guiding Catheter Cotton-Huibregtse(R) Biliary Stent Zimmon® Biliary Stent Set Stent Introducer Set ST-2 Soehendra® Tannenbaum® Biliary Stent Cotton-Huibregtse® Biliary Stent Set Cotton-Leung Biliary Stent Set Zimmon(R) Biliary stent Guiding Catheter Cotton-Leung® (Amsterdam) Biliary Stent Set Oasis® Stent Introduction System Oasis® One Action Stent Introduction System Cotton-Leung® Biliary Stent Huibregtse-Katon Pusher Pushing Catheter Cotton Leung

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198