BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Endophys Pressure Sensing Sheath Kit

    Reg #: 3011493920 · FEI: 3011493920 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ENDOPHYS HOLDINGS, LLC
    Registration Number
    3011493920
    FEI Number
    3011493920
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1933 E. Levee, Suite B
    City
    Dallas
    State
    TX
    ZIP
    75207
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180620

    Owner / Operator

    Firm Name
    Endophys Holdings, LLC
    Operator Number
    10048994
    Address
    1601 Elm Street, Suite 1965
    City
    Dallas
    State
    TX
    Postal Code
    75201
    Country
    US
    Correspondent
    Zachary Sowell

    Products

    Device Name Product Code
    Transducer, Pressure, Catheter Tip DXO
    Introducer, Catheter DYB

    Proprietary Names

    Endophys Pressure Sensing Sheath Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility