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The Amplatzer Piccolo™ Delivery System is indicated to facilitate the delivery of an Amplatzer Piccolo™ Occluder through the heart of a patient with a patent ductus arteriosus.

The Amplatzer Piccolo Delivery System is designed to facilitate the delivery of an Amplatzer Piccolo™ Occluder into a patent ductus arteriosus (PDA). The Amplatzer Piccolo Delivery System consists of a delivery catheter, loader, Tuohy-Borst hemostasis valve with extension tube and stopcock, and self-sealing hemostasis valve. The Amplatzer Piccolo Delivery System is available in a 4 Fr size with a usable length of 45 cm. The delivery system components have the following performance characteristics:

• Delivery catheter: Provides a pathway through which an occluder is delivered. The body of the catheter is radiopaque for visibility under fluoroscopy. The distal end of the catheter has a curve that is optimized to allow co-axial placement of the delivery catheter within the PDA. A curve indicator is located on the hub as an additional reference for the direction of the curvature.
• Tuohy-Borst hemostasis valve with extension tube and stopcock: Allows flushing of the delivery catheter and controls blood backflow.
• Loader: Introduces an occluder into the delivery catheter.
• Self-sealing hemostasis valve: Allows flushing of the loader and delivery catheter and controls blood backflow.

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