BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSIGHTRA MEDICAL, INC.

    Reg #: 2032677 · FEI: 3003945344 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    INSIGHTRA MEDICAL, INC.
    Registration Number
    2032677
    FEI Number
    3003945344
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2543 Madison St, Unit 105
    City
    Clarksville
    State
    TN
    ZIP
    37043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082746

    Owner / Operator

    Firm Name
    INSIGHTRA MEDICAL, INC.
    Operator Number
    9054804
    Address
    2543 Madison St., #105
    City
    Clarksville
    State
    TN
    Postal Code
    37043
    Country
    US
    Correspondent
    Sandie Hetland

    Products

    Device Name Product Code
    Accessories, Catheter KGZ
    Retractor GAD
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    System, Balloon, Intra-Aortic And Control DSP
    Instrument, Manual, Surgical, General Use MDM
    Ligator, Hemorrhoidal FHN
    Endoscopic Contamination Prevention Sheath ODB
    Arthroscope HRX
    Accessories, Arthroscopic NBH
    Device, Intravascular Catheter Securement KMK
    Syringe, Balloon Inflation, Exempt PTM

    Proprietary Names

    Catheter Retractor Hemostasis Y Connector Kit Ultra IABP 7FR Cathether Kit INSTRUMENT, MANUAL Ligator endoscopic contamination prevention sheath Arthroscope Double Pump Cassettes Ultra IAB Catheter Insightra Balloon Inflation Device

    Establishment Types

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