Device Dossier

PowerLine™ Polyurethane Catheter with SureCuff Ingrowth Cuff, AirGuard, Intermediate Kit - Catheter, intravascular, infusion, central venous

Device Dossier for PowerLine™ Polyurethane Catheter with SureCuff Ingrowth Cuff, AirGuard, Intermediate Kit - Catheter, intravascular, infusion, central…

Intended purpose

The PowerLine™ catheter is indicated for short or long term access to the central venous system. PowerLine™ catheters are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal. In addition PowerLine™ catheters allow for power injection of contrast media and central venous pressure monitoring. The maximum recommended infusion rate is 5 mL/sec. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Functional description

A family of Central Venous Catheters made from specially formulated and processed medical grade polyurethane and materials. PowerLine™ catheters have a kink-resistant, reverse-tapered design. The SureCuff™ Tissue Ingrowth Cuff promotes tissue ingrowth to secure the catheter in place. The catheters are radiopaque with female luer locking adapters and StatLock® Stabilization Device compatible suture wing fixation. Each catheter is provided in a sterile package.

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