BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SiteSeal 01

    Reg #: 3020031299 · FEI: 3020031299 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ENSITEVASCULAR, LLC
    Registration Number
    3020031299
    FEI Number
    3020031299
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10561 Barkley St Ste 610
    City
    Overland Park
    State
    KS
    ZIP
    66212
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192413

    Owner / Operator

    Firm Name
    EnsiteVascular, LLC
    Operator Number
    10082533
    Address
    10561 Barkley St., Ste 610
    City
    Overland Park
    State
    KS
    Postal Code
    66212
    Country
    US
    Correspondent
    Thomas J Reidy

    Products

    Device Name Product Code
    Clamp, Vascular DXC

    Proprietary Names

    SiteSeal 01

    Establishment Types

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