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The Dexterity™ Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

The Cardiosolutions Dexterity™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of the following components based on the model#: Size and Working Length: 14FR 65 and 85 CM, Included Accessories: Dilator, Stylet, Tear-away introducer sheath Size and Working Length: 14Fr 105 CM, Included Accessories: Dilator, NA, Tear-away introducer sheath Size and Working Length: 9Fr 65CM, Included Accessories: NA, Curved Stylet, NA The Dexterity steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in various diameters and working lengths. The device is provided sterile and is intended for single use only. The purpose of this submission is to add an additional device working length, 105 CM, to the 14Fr Introducer product offering. In addition the intended use statement is modified to include the term percutaneous for clarification only. This change is not a change to the intended use of the device.

The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

The Cardiosolutions Percu-Pro™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of a dilator (14Fr only), stylet, and tear-away introducer sheath. The steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in 65 cm working lengths. The device is provided sterile and is intended for single use only. The purpose of this submission is to add an additional device diameter; 9Fr has 65 cm working lengths.

The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.

The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax and the distal tip balloon is made from latex.

The Percu-Pro™ Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.

The Percu-Pro™ GuideWire is constructed of a stainless steel core wire The proximal end of the core and is finished with a PTFE jacket. The coil covered distal end of the core is tapered to a ribbon tip to increase flexibility and is finished with a silver brazed ball tip. The guidewire is provided sterile and is a single use device.