Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K000456
    Device Name
    HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2
    Manufacturer
    HARVEST TECHNOLOGIES, LLC.
    Date Cleared
    2000-06-01

    (111 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARVEST TECHNOLOGIES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K991430
    Device Name
    SMARTPREP CENTRIFUGE SYSTEM
    Manufacturer
    HARVEST TECHNOLOGIES, LLC.
    Date Cleared
    1999-05-28

    (32 days)

    Product Code
    JQC
    Regulation Number
    862.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARVEST TECHNOLOGIES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
    Device Description
    SmartPReP Centrifuge System: Includes a table-top, self-decanting, swinging bucket centrifuge and processing disposable designed to allow for rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 6000 rpms at a maximum force of approximately 3550g.
    Ask a Question
    K Number
    K983022
    Device Name
    SMARTCELL PROCESSING SYSTEM
    Manufacturer
    HARVEST TECHNOLOGIES, LLC.
    Date Cleared
    1999-04-02

    (214 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARVEST TECHNOLOGIES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartCell™ Processing System is indicated for the processing of autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion.
    Device Description
    The SmartCell System includes the following two components: Reusable SC-1000, SmartCell hardware system that includes the following major system components: start/stop/clear buttons, process indicator display, process indicator lights, HES and blood pumps, two processing chambers (left and right), fluid sensors, optics and drain controls. The system also includes the electronic components and system software that monitors proper installation of the disposable and the sedimentation process. The SCP-1500, Process Pack: a sterile, disposable device to transfer and contain the blood and sedimentation fluid (HES) during concentration and transfer to the preconnected filtered reinfusion bag. Also a separate disposable Processing Bag (SCP-1550) is provided that is a sub-assembly of the Process Pack. The SCP-1550 is provided to allow for processing of additional volumes of blood.
    Ask a Question

    Page 1 of 1