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510(k) Data Aggregation

    K Number
    K150800
    Device Name
    Valved Safety Centesis Catheter
    Manufacturer
    B. Braun Medical Inc
    Date Cleared
    2015-11-12

    (231 days)

    Product Code
    GCB
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    GCB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.
    Device Description
    The Valved Safety Centesis Catheter is a drainage, centesis catheter with a self sealing valve and a passive safety needle-shielding feature. The catheter is designed with drainage holes located around the distal tip of the catheter to facilitate the drainage of fluid. The catheter surface and tapered end is designed for smooth transition through the tissue, while the inner surface is designed for easy retraction of the insertion needle. The insertion needle comes with a vent plug that allows air to exit and does not allow fluid to exit. The echogenic needle tip provides a guidance for proper catheter placement using ultrasound. The needle hub is clear and locks within the catheter hub. The catheter is radiopaque and can be visualized using fluoroscopy. The hub of the catheter contains a luer adapter to facilitate attachment of drainage collection devices and a bevel indicator for needle bevel orientation reference. The device is provided individually packaged sterile.
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    K Number
    K974146
    Device Name
    PARACENTESIS CATHETER DEVICE
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Date Cleared
    1998-01-28

    (86 days)

    Product Code
    GCB
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    GCB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.
    Device Description
    The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.
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