BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TANDEM Microspheres

    Reg #: 3008262715 · FEI: 3008262715 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    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
    K141209

    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
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Device, Vascular, For Promoting Embolization KRD

    Proprietary Names

    TANDEM Microspheres ONCOZENE® Microspheres

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device