BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PrecisionTAVI

    Reg #: 3030707552 · FEI: 3030707552 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DASISIMULATIONS, LLC
    Registration Number
    3030707552
    FEI Number
    3030707552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6500 Emerald Pkwy, Suite 200
    City
    Dublin
    State
    OH
    ZIP
    43016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223809

    Owner / Operator

    Firm Name
    Dasisimulations, LLC
    Operator Number
    10090418
    Address
    6500 Emerald Pkwy, Suite 200
    City
    Dublin
    State
    OH
    Postal Code
    43016
    Country
    US
    Correspondent
    Manali Shah

    Products

    Device Name Product Code
    Interventional Cardiovascular Implant Simulation Software Device QQI

    Proprietary Names

    PrecisionTAVI

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198