BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design With Nitinol Wire Guide

    Reg #: 1820334 · FEI: 1820334 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Cook Incorporated
    Registration Number
    1820334
    FEI Number
    1820334
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    750 DANIELS WAY
    City
    Bloomington
    State
    IN
    ZIP
    47404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240589

    Owner / Operator

    Firm Name
    COOK, INC.
    Operator Number
    1820334
    Address
    750 DANIELS WAY
    City
    Bloomington
    State
    IN
    Postal Code
    47404
    Country
    US

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design With Nitinol Wire Guide Micropuncture® Introducer Set With Cope Platinum-Tipped Stainless Steel Wire Guide Micropuncture® Pedal Access Set Silhouette® Transitionless - with Nitinol Wire Guide and Hemostatic Valve Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design - STIFFENED CANNULA With Nitinol Wire Guide Micropuncture® Introducer Set With Nitinol Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless With Cope Platinum-Tipped Stainless Steel Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless With Platinum-Tipped Stainless Steel Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design - STIFFENED CANNULA With Stainless Steel Wire Micropuncture® Introducer Set Silhouette® Transitionless With Stainless Steel Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless With Nitinol Wire Guide Micropuncture® Introducer Set Silhouette® Transitionless Design with Nitinol Wire Guide and EchoTip® Needle Micropuncture® Introducer Set With Stainless Steel Wire Guide

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device