BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Endophys Pressure Sensing Sheath Kit

    Reg #: 3005232773 · FEI: 3005232773 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Teleflex Medical OEM LLC
    Registration Number
    3005232773
    FEI Number
    3005232773
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3750 Annapolis Ln N Ste 160
    City
    Plymouth
    State
    MN
    ZIP
    55447
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160272

    Owner / Operator

    Firm Name
    Teleflex
    Operator Number
    9062981
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    Products

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

    Proprietary Names

    Endophys Pressure Sensing Sheath Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)