BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IntelliBlate Microwave Ablation System Console (IB-CON)

    Reg #: 3008262715 · FEI: 3008262715 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Varian Medical Systems, Inc
    Registration Number
    3008262715
    FEI Number
    3008262715
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9825 Spectrum Drive, Building 2
    City
    Austin
    State
    TX
    ZIP
    78717
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240480

    Owner / Operator

    Firm Name
    Varian Medical Systems, Inc
    Operator Number
    2914292
    Address
    3100 Hansen Way, --
    City
    Palo Alto
    State
    CA
    Postal Code
    94304
    Country
    US

    Products

    Device Name Product Code
    System, Ablation, Microwave And Accessories NEY

    Proprietary Names

    IntelliBlate Microwave Ablation System Console (IB-CON) IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315) IntelliBlate Microwave Ablation System Mobile Cart (IB-CART) IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320)

    Establishment Types

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