BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AGILITY®9 Steerable Guidewire and NEUROSCOUT®@ Steerable Goidewire

    Reg #: 3006283319 · FEI: 3006283319 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NeedleTech Products, Inc.
    Registration Number
    3006283319
    FEI Number
    3006283319
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    452 John L Dietsch Blvd
    City
    N Attleboro
    State
    MA
    ZIP
    02763
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133625

    Owner / Operator

    Firm Name
    Theragenics Corporation
    Operator Number
    1037598
    Address
    5203 BRISTOL INDUSTRIAL WAY, --
    City
    Buford
    State
    GA
    Postal Code
    30518
    Country
    US

    Products

    Device Name Product Code
    Guide, Wire, Catheter, Neurovasculature MOF
    Wire, Guide, Catheter DQX

    Proprietary Names

    AGILITY®9 Steerable Guidewire and NEUROSCOUT®@ Steerable Goidewire

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)