BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HeartSpan Fixed Curve Braided Transseptal Sheath

    Reg #: 1724474 · FEI: 3003094851 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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
    K132720

    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
    Introducer, Catheter DYB

    Proprietary Names

    HeartSpan Fixed Curve Braided Transseptal Sheath EZ Cross Introducer, et. al. Braided Guiding Introducer CardiaGuide Fixed Curve Braided Trasseptal Sheath

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)