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The Cultiv8 Genie MAX is intended to be inserted into the vasculature to provide a conduit for introducing intravascular devices while providing a hemostatic seal to minimize blood loss.

The Genie MAX is a large bore introducer sheath system used for providing a conduit for introduction of intravascular devices while providing a hemostatic seal. The system includes an introducer sheath, protector, dilator and a 3cc syringe.

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The Reprocessed Agilis NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Reprocessed Agilis NxT Steerable Introducer consists of a dilator, guidewire, and bi-directional steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The device has either a small, medium, or large curl at the distal tip. The sheath handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. The sheath material consists of braided stainless-steel wire covered with Pebax (polyether block amide) and Nylon. The sheath is filled with barium sulfate and the distal tip has a platinum/iridium marker for visualization under fluoroscopy. A plastic dilator and stainless-steel guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.

Note: Only the steerable sheath and dilator are the subject (reprocessed devices) of this submission. The guidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.

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The Medline ReNewal Reprocessed Abbott Agilis NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Medline ReNewal Reprocessed Agilis NxT Steerable Introducer consists of a dilator, guidewire, and a bi-directional steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The device has either a small, medium, or large curl at the distal tip. The sheath handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. The sheath material consists of braided stainless-steel wire covered with Pebax (polyether block amide) and Nylon. The sheath is filled with barium sulfate, and the distal tip has a platinum/iridium marker for visualization under fluoroscopy. A plastic dilator and stainless-steel guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.

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The Intri26 Introducer Sheath is indicated:

• To provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
• For the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Intri26 Introducer Sheath is an introducer sheath consisting of a short, single-lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid fluoroscopic visualization. The Intri26 dilator is compatible with a 0.035" guidewire and has a tapered leading edge, which aids insertion and positioning of the sheath.

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The V•Stick™ Vascular Access Set is intended for use in the introduction and placement of guidewires and/or catheters.

The V•Stick™ Vascular Access Set consists of a 4F or 5F coaxial introducer set (with a 3F standard or 3F stiff dilator), a 21ga entry needle (with an echogenic or non-echogenic tip), and a 0.018" x 40cm Nitinol core and with Stainless Steel coil vascular access guidewire with an articulatable tip.

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PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

Each PerQseal Introducer ('S', 'L', Elite 14F, and Elite 18F) includes an Introducer Sheath with a Dilator positioned within the lumen. The Introducer Sheath comprises a simple sheath that provides access to the site, while the Dilator is a component which guides the Introducer Sheath to the access site and provides a blood signal that is used to ensure proper positioning of the Introducer Sheath.

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The Introducer Sheath set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

The Introducer Sheath Set consists of a sheath and a dilator. The sheath is comprised of a sheath tube, a sheath hub, and a hemostatic valve. While the dilator comprises a dilator hub, a dilator tube and a rod cap. The sheath features a hydrophilic coating. Each set of products is equipped with a sheath and a dilator. The product is sterilized with ethylene oxide and is disposable.

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The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Introducer Kit is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion.

The Abiomed 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end and a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

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The Primero Safe Access System is intended to facilitate placing a catheter through the skin into a vein or artery. The introducer needle is used in facilitating entry through the skin into a vein or artery to provide a conduit for the guidewire. The guidewire is an accessory device which is used for placement of a catheter or sheath in the vein or artery.

The Primero Safe Access System (SAS) is a catheter introducer that facilitates a quick approach for placement of a guidewire during the introduction of a catheter for vascular access. The Primero SAS combines an introducer needle, guidewire, advancer, and storage tube into a single integrated device to promote ease of use and quick access by the healthcare provider. The introducer needle consists of an 18Ga stainless steel needle with an echogenic tip and terminates on the proximal end with a colored translucent standard female luer lock hub. The introducer needle has an enhanced echogenic tip, that has been slightly modified to incorporate a small bulb-like feature at the proximal end of the tip bevel to enhance ultrasonic visualization during vascular access. The introducer needle is secured to the advancer through a luer lock connector at the distal end of the advancer. The advancer is a light-weight polymer handpiece that allows the user to grip the entire setup while introducing the needle into the vessel and then advancing the guidewire through the needle by either 'thumb" or 'two-finger" advancing based on the preference of the user. A cutout in the advancer handpiece wire path exposes the guidewire and conveniently allows the user to advance the guidewire with their fingers without having to let go of the handpiece. An internal path within the handpiece feeds the guidewire from a storage tube into the introducer needle. The looped storage tube is connected to the proximal end of the advancer and holds a spooled pre-loaded guidewire ready for deployment. A back stop has been inserted into the tube at the proximal end to prevent a guidewire from being over-retracted from the advancer. The Primero SAS is pre-loaded with a commercially available guidewire (previously cleared under K142393) ready for deployment through the introducer needle once placed in the target vessel. The guidewire is comprised of an uncoated nitinol core wire that is tapered at the distal tip where a stainless-steel coil is secured over the full-length of the core. The South53 Primero Safe Access System (SAS) integrates all the necessary elements into a single device to complete the Seldinger technique as part of a vascular access procedure.

The Primero SAS is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used.

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The Pounce™ Sheath is intended to introduce therapeutic or diagnostic devices into the vasculature.

The Pounce™ Sheath 16Fr is a single-use, sterile introducer sheath intended for the introduction of therapeutic or diagnostic devices within the vasculature. The Pounce™ Sheath 16Fr includes the following features:

• Braided nitinol, self-expanding funnel at the sheath's distal end
• Handle assembly with slider button to actuate the funnel's deployment
• Hub and hemostasis valve assembly to allow for device introduction and removal
• Aspiration assembly including tubing, a stopcock, and connection for a 60 cc syringe

Additional components provided within the packaging include:

• 0.035" guidewire compatible pre-dilator for access site preparation
• 0.035" guidewire compatible dilator designed for atraumatic introduction of the sheath
• 60 cc locking syringe, compatible with the sheath's aspiration assembly

A radiopaque marker band is located at the distal tip of the sheath during introduction and removal, when the funnel is sheathed. When the funnel is unsheathed, the radiopaque marker band is located proximally to the funnel. The funnel is sheathed and unsheathed with the actuation of a slider button located on the handle assembly. The hemostasis valve can be actively defeated (opened), during device introduction or removal, by pressing down on the base of the surrounding hub. This action is designed to minimize device contact across the hemostatic valve during the introduction or removal of devices. The aspiration assembly also aids in the delivery of contrast or saline.

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