BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIRTEX MEDICAL INC.

    Reg #: 3012690638 · FEI: 3012690638 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    SIRTEX MEDICAL INC.
    Registration Number
    3012690638
    FEI Number
    3012690638
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    300 Unicorn Park Dr., 2nd Fl.,
    City
    Woburn
    State
    MA
    ZIP
    01801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202392
    PMA Number
    P220020

    Owner / Operator

    Firm Name
    Sirtex Medical Inc.
    Operator Number
    9047689
    Address
    300 Unicorn Park Dr., 2nd Fl.
    City
    Woburn
    State
    MA
    Postal Code
    01801
    Country
    US
    Correspondent
    Jeffrey Cyr

    Products

    Device Name Product Code
    Holder, Syringe, Lead IWR
    Shield, Protective, Personnel KPY
    Embolization Agent, Vascular QVG
    Shield, Vial IWW
    System, Tomography, Computed, Emission KPS
    System, Applicator, Radionuclide, Manual IWJ
    Microspheres Radionuclide NAW

    Proprietary Names

    Syringe Shield SIR-Spheres Delivery Box SIROS Delivery Dome LAVA Mixing Kit LAVA Liquid Embolic System (Lava LES) and LAVA Mixing Kit LAVA Liquid Embolic System (LES) LAVA Liquid Embolic System (LES) Kit SIROS D-Vial Prep Set SIR-Spheres V-Vial Holder SIR-Spheres Microspheres Activity Calculator (SMAC) SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIR-Spheres V-Vial SIROS Delivery Set V-Vial SIR-Spheres SIR-Spheres Select Y-90 resin microspheres SIR-Spheres Select SIR-Spheres microspheres

    Establishment Types

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