BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOSENSE WEBSTER, INC.

    Reg #: 3022451073 · FEI: 3022451073 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOSENSE WEBSTER, INC.
    Registration Number
    3022451073
    FEI Number
    3022451073
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23 Hubble Drive
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252972

    Owner / Operator

    Firm Name
    BIOSENSE WEBSTER, INC.
    Operator Number
    9044811
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Tucky Wong

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    CARTO 3 EP Navigation System V8.4 CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) CARTO 3 EP Navigation System Version 7.2 CARTO 3 system version 8 CARTO 3 System v6 with VISITAG SURPPOINT CARTO 3 EP Navigation System, Version 6 CARTO 3 System and Accessories, version 4.3.5 with Coherent Mapping CARTO™ 3 EP Navigation System V8.1

    Establishment Types

    Manufacture Medical Device