BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Surefire Medical, Inc.

    Reg #: 3010909876 · FEI: 3010909876 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Surefire Medical, Inc.
    Registration Number
    3010909876
    FEI Number
    3010909876
    Status
    Active
    Expiry Year
    2026
    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
    Catheter, Percutaneous DQY
    Catheter, Continuous Flush KRA

    Proprietary Names

    TriNav FLX Infusion System TriNav Infusion System Spark Infusion System TriSalus TriGuideTM Guiding Catheter TriSalus Infusion System TriSalus TriNav® XP Infusion System TriSalus TriNav® LV Infusion System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device