BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection

    Reg #: 3011471056 · FEI: 3011471056 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CONTEGO MEDICAL, INC
    Registration Number
    3011471056
    FEI Number
    3011471056
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3801 Lake Boone Trail, Suite 100
    City
    Raleigh
    State
    NC
    ZIP
    27607
    Country
    US

    Regulatory Submissions

    PMA Number
    P240009

    Owner / Operator

    Firm Name
    Contego Medical, INC
    Operator Number
    10050012
    Address
    3801 Lake Boone Trail, Suite 100
    City
    Raleigh
    State
    NC
    Postal Code
    27607
    Country
    US
    Correspondent
    James Clossick

    Products

    Device Name Product Code
    Stent, Carotid NIM

    Proprietary Names

    Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198