BEUDAMED
    FDA Registration Active 🇺🇸 United States

    1.7 RX Turbo-Elite

    Reg #: 1724474 · FEI: 3003094851 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Terumo BCT STERILIZATION SERVICES, Inc.
    Registration Number
    1724474
    FEI Number
    3003094851
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11308 W Collins Ave
    City
    LAKEWOOD
    State
    CO
    ZIP
    80215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170059

    Owner / Operator

    Firm Name
    Terumo BCT, INC.
    Operator Number
    9002708
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80215
    Country
    US
    Correspondent
    Corrine Lucas

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    1.7 RX Turbo-Elite 2 RX Turbo-Elite 2 OTW Turbo-Elite 2.3 OTW Turbo-Elite 2.5 OTW Turbo-Elite, OUS 0.9 OTW Turbo-Elite 0.9 RX Turbo-Elite 2.3 OTW Turbo-Elite, OUS 1.4 OTW Turbo-Elite 2.5 OTW Turbo-Elite, US 2.5 OTW Turbo-Elite 2.3 OTW Turbo-Elite, US 1.4 RX Turbo-Elite 1.7 OTW Turbo-Elite

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)