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The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The Breezeway II-Delivery Sheath consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, and dilator. The Breezeway II Plus models include these same components plus a loader accessory. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.

The steerable guiding sheath, Destino Reach is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The Destino Reach Steerable Guiding Sheath is a percutaneous steerable sheath designed to facilitate the intracardiac, renal and peripheral placement of diagnostic and therapeutic devices. The device features an adjustable tip through use of a rotating collar that allows the physician to perform a bi-deflection at the distal tip section of the sheath. The sheath has a hemostatic valve, sideport with stopcock, radiopaque distal tip, contains side flush portholes and is deflectable by rotating the collar incorporated into the handle. The dilator has depth markings and locks onto the sheath. The dilator has a tapered distal tip and an inner lumen recommended for use with 0.035" to 0.038" guidewire and/or transseptal needle.

The IS4/DF4 plug can be indicated for a patient with an implantable pacemaker/defibrillator that has an unused IS4/DF4 receptacle. The plug prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle.

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The Adelante® Magnum is intended to facilitate the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements, while minimizing blood loss associated with such insertions. Do not use this device for neural placements.

Introducer, Model Adelante® Magnum

The steerable guiding sheath, model Destino Twist is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements

Steerable Guiding Sheath, model Destino Twist

The Adelante® Radial Introducer Set is indicated for the introduction of diagnostic and therapeutic catheters into the human vasculature. Do not use this device for neural placements.

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Indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

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The guidewire is intended to facilitate the introduction of intravascular devices for use in the coronary and/or peripheral vasculature during diagnostic and interventional procedures.

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The Adelante® Breezeway Delivery Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.

The steerable guiding sheath, model Adelante Destino is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. There is no modification to the device itself. The Adelante Destino Steerable Guiding Sheath has been cleared in K120459 and will remain intact and no modification to product labels.