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The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath and Dilator is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Advance Steerable Sheath and Dilator can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This premarket notification presents proposed design and material changes to the hemostasis valve component, located within the handle section. Product performance requirement changes related to the updated hemostasis valve are also being implemented for the subject device. All other aspects of the device (overall design/technology, labeling, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance Steerable Sheath and Dilator cleared under K183174.

The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The FlexCath Advance Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This premarket notification presents proposed updates to the Instructions for Use (IFU) manual; changes resulting in the subject device are limited to these IFU updates only. All other aspects of the device (design/technology, performance specifications, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance originally cleared under K123591.

The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.

The Medtronic FlexCath™ Select Steerable Sheath is a sterile, single-use, percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and exchange of catheters and wires while minimizing blood loss. A side port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. A dilator is packaged with the FlexCath Select. The handle incorporates a deflection mechanism and a deflection wire that is integrated into the catheter shaft. This allows the sheath to be deflected to provide additional maneuverability to catheters that are advanced through the sheath into the right or left chamber of the heart. The FlexCath Select sheath is comprised of two (2) main sections: the shaft and the handle.

The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.

The FlexCath Select Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Select Steerable Sheath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Select Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application introduces FlexCath Select 10 French (10Fr) FlexCath Select Steerable Sheath (990065), which is a modification of the 12 French (12Fr) FlexCath Advance Sheath (4FC12). Modifications were made to the shaft, cap and strain relief components, hemostasis valve assembly (stopcock, valve, and hub), dilator, new adhesive material and packaging tray cavity.

The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Advance Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application addresses modifications to the 12 French (12F) FlexCath Steerable Sheath which resulted in the creation of the 12F FlexCath Advance Steerable Sheath (4FC12). Modifications were made to the stopcock, shaft (pullwire and ring assembly), deflection stopper, and barrel and slider assembly. In addition, an updated Technical Manual (Instructions for Use) and updated packaging labeling was developed for the FlexCath Advance Steerable Sheath.

The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Steerable Sheath is a deflectable catheter introducer used to facilitate placement of a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application addresses changes to the 12F FlexCath sheath tip and valve assembly.