BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Haemonetics Cell Saver Elite Autotransfusion System

    K Number: K160197 · Decision May 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    7
    Review Days
    118

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    Basic Information

    Device Name
    Haemonetics Cell Saver Elite Autotransfusion System
    K Number
    K160197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Haemonetics Corporation
    Date Received
    January 27, 2016
    Decision Date
    May 24, 2016
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAC Apparatus, Autotransfusion

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    Other Clearances by Haemonetics Corporation

    K Number Device Name
    K243858 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
    K232018 Citrated: K, KH, RTH, FFH
    K221722 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
    K183160 TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
    K160502 TEG 6s Hemostasis System
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