BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSITU TECHNOLOGIES, INC.

    Reg #: 2134244 · FEI: 3003407487 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    INSITU TECHNOLOGIES, INC.
    Registration Number
    2134244
    FEI Number
    3003407487
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1301 Corporate Center Dr Ste 160
    City
    Saint Paul
    State
    MN
    ZIP
    55121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060551

    Owner / Operator

    Firm Name
    INSITU TECHNOLOGIES, INC.
    Operator Number
    9032211
    Address
    1301 Corporate Center Drive, #160
    City
    Eagan
    State
    MN
    Postal Code
    55121
    Country
    US
    Correspondent
    Amjad Ahmad

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Coronary Drug-Eluting Stent NIQ
    Catheter, Intravascular, Diagnostic DQO
    Iliac Covered Stent, Arterial PRL
    Introducer, Catheter DYB
    Coronary Covered Stent NIV
    Drug-Coated Peripheral Transluminal Angioplasty Catheter PRC

    Proprietary Names

    Radial Siro Drug Eluting Stent Rainbow Arriva Silene Peripheral Covered Stent StarFlex Silene Celosia Aaris DCB Catheter Aaris Starflex, Rainbow

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Device in the United States for Export Only