BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pentaray Nav High-Density Mapping Catheter

    Reg #: 3013300026 · FEI: 3013300026 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOSENSE WEBSTER, INC.
    Registration Number
    3013300026
    FEI Number
    3013300026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120425

    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
    Maria Jose Arana

    Products

    Device Name Product Code
    Catheter, Intracardiac Mapping, High-Density Array MTD

    Proprietary Names

    Pentaray Nav High-Density Mapping Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility