BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Spectra Optia Apheresis System

    K Number: K181049 · Decision Nov 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    8
    Review Days
    195

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    Basic Information

    Device Name
    Spectra Optia Apheresis System
    K Number
    K181049
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumobct, Inc.
    Date Received
    April 20, 2018
    Decision Date
    November 1, 2018
    Product Code
    LKN
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

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    Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter

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    Other Clearances by Terumobct, Inc.

    K Number Device Name
    K183081 Spectra Optia Apheresis System
    K172590 Spectra Optia Apheresis System
    K162365 T-Cuff
    K153601 Spectra Optia Apheresis System
    K141938 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
    K132429 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
    K131744 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE