BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CorPath GRX System with Rotate on Retract

    Reg #: 3022099867 · FEI: 3022099867 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Siemens Healthineers Endovascular Robotics, Inc.
    Registration Number
    3022099867
    FEI Number
    3022099867
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    275 Grove Street, Suite 1-110
    City
    Newton
    State
    MA
    ZIP
    02466
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180517

    Owner / Operator

    Firm Name
    Siemens Healthineers Endovascular Robotics, Inc.
    Operator Number
    10039855
    Address
    275 Grove Street, Suite 1-110
    City
    Newton
    State
    MA
    Postal Code
    02466
    Country
    US
    Correspondent
    Marites Yamut

    Products

    Device Name Product Code
    System, Catheter Control, Steerable DXX

    Proprietary Names

    CorPath GRX System with Rotate on Retract CorPath GRX Robotic Drive CorPath GRX Extended Reach Arm CorPath Robotic-Assisted System CorPath GRX Control Console CorPath GRX Drive Gear technIQ CorPath GRX Cassette CorPath GRX System with technIQ CorPath GRX System with RoR CorPath GRX System

    Establishment Types

    Manufacture Medical Device