Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021927
    Device Name
    PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
    Manufacturer
    BIOMET, INC.
    Date Cleared
    2002-07-12

    (30 days)

    Product Code
    LXG
    Regulation Number
    862.2050
    Why did this record match?
    Product Code :

    LXG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Platelet Concentrate Separation kit is designed for use in the clinical laboratory or intra-operatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60 ml) of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.
    Device Description
    The platelet concentrate separation kit aids separation of the patient's own blood components by density through the use of a centrifuge. The platelet concentration kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient blood that is drawn at the time of treatment. Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 ¼" catheter, 60 ml piston syringe, 30 ml piston syringe, 1 ml piston syringe, petri dish, rubber tubing tourniquet, gauze pad, alcohol pad, adhesive tape, silicone tube, volume gauge, PETG tray with sealed Tyvek® lid
    Ask a Question

    Page 1 of 1