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510(k) Data Aggregation

    K Number
    K092597
    Device Name
    CENTROS CHRONIC HEMODIALYSIS CATHETER SET
    Manufacturer
    ASH ACCESS TECHNOLOGY, INC.
    Date Cleared
    2009-11-12

    (80 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASH ACCESS TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Centros™ Chronic Hemodialysis Catheter Set is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days long-term placement.
    Device Description
    The Centros® Chronic Hemodialysis Catheter Set is a dual lumen, 15FR catheter available in multiple lengths, in straight and pre-curved configurations. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length split-tip, without side-holes. The distal venous lumen extends past the arterial lumen, and includes a guidewire slit for insertion by the optional guidewire placement technique. The proximal device contains a fixed polyester cuff, an integrated hub, suture wing, and extension set with color coded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.
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    K Number
    K070572
    Device Name
    ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM
    Manufacturer
    ASH ACCESS TECHNOLOGY, INC.
    Date Cleared
    2007-06-26

    (118 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASH ACCESS TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ash Advance™ Hemodialysis Catheter and Procedure Kit is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days long-term placement.
    Device Description
    The Ash Advance™ Hemodialysis Catheter and Procedure Kit is a dual lumen, 15FR catheter available in multiple lengths. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length split-tip, without rom radiopaque Caro venous lumen extends past the arterial lumen, and includes a guidewire slit for insertion by the optional guidewire placement technique. The proximal device contains a fixed polyester cuff, an integrated hub, suture wing, and extension set with color coded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.
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