BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ConturaFlex MLB Catheter with Introducer

    Reg #: 1222780 · FEI: 1000120743 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HOLOGIC, INC.
    Registration Number
    1222780
    FEI Number
    1000120743
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    250 Campus Dr
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081079

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    System, Applicator, Radionuclide, Remote-Controlled JAQ

    Proprietary Names

    ConturaFlex MLB Catheter with Introducer Contura Accessory kit ConturaFlex MLB Catheter without Introducer Contura Introducer and Split Sheath Contura MLB Catheter without Introducer Contura MLB Catheter with Introducer

    Establishment Types

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