BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HeartFlow FFRCT Analysis

    Reg #: 3021637148 · FEI: 3021637148 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HEARTFLOW, INC.
    Registration Number
    3021637148
    FEI Number
    3021637148
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    331 E Evelyn Ave
    City
    Mountain View
    State
    CA
    ZIP
    94041
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213857

    Owner / Operator

    Firm Name
    HeartFlow, Inc.
    Operator Number
    10048116
    Address
    331 E Evelyn Ave
    City
    Mountain View
    State
    CA
    Postal Code
    94041
    Country
    US
    Correspondent
    Emre Gulturk

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Coronary Vascular Physiologic Simulation Software PJA

    Proprietary Names

    HeartFlow FFRCT Analysis

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device