BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection

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

    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

    510(k) Number
    K181128

    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
    Temporary Carotid Catheter For Embolic Capture NTE
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection

    Establishment Types

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