BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter

    Reg #: 3005467144 · FEI: 3005467144 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NORTHEAST SCIENTIFIC, INC.
    Registration Number
    3005467144
    FEI Number
    3005467144
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2142 Thomaston Ave
    City
    Waterbury
    State
    CT
    ZIP
    06704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220171

    Owner / Operator

    Firm Name
    NORTHEAST SCIENTIFIC, INC.
    Operator Number
    9079660
    Address
    2142 Thomaston Avenue, --
    City
    Waterbury
    State
    CT
    Postal Code
    06704
    Country
    US
    Correspondent
    Matt - Farley

    Products

    Device Name Product Code
    Reprocessed Atherectomy Catheter QTF

    Proprietary Names

    NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 2mm OTW Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter NES Reprocessed 2mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device