BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VYCOR MEDICAL INC

    Reg #: 3005880844 · FEI: 3005880844 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    VYCOR MEDICAL INC
    Registration Number
    3005880844
    FEI Number
    3005880844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    951 BROKEN SOUND PKWY STE 320
    City
    Boca Raton
    State
    FL
    ZIP
    33487
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060973

    Owner / Operator

    Firm Name
    VYCOR MEDICAL INC
    Operator Number
    9085664
    Address
    951 Broken Sound Pkwy, Suite 320
    City
    Boca Raton
    State
    FL
    Postal Code
    33487
    Country
    US

    Products

    Device Name Product Code
    Retractor, Self-Retaining, For Neurosurgery GZT

    Proprietary Names

    VYCOR VIEWSITE SUR Vycor Medical Viewsite Brain Access System with Alignment Clip (“VBAS AC”)

    Establishment Types

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