BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spark Infusion System

    Reg #: 3010909876 · FEI: 3010909876 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Surefire Medical, Inc.
    Registration Number
    3010909876
    FEI Number
    3010909876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6272 W 91st Ave
    City
    Westminster
    State
    CO
    ZIP
    80031
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180677

    Owner / Operator

    Firm Name
    TriSalus Life Sciences
    Operator Number
    10038066
    Address
    6272 W. 91st Avenue
    City
    Westminster
    State
    CO
    Postal Code
    80031
    Country
    US

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO

    Proprietary Names

    Spark Infusion System TriNav Infusion System TriNav FLX Infusion System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device