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Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.

Integra® Jarit® Heparin Cannulas, Injectors, and Needles are manual, stainless steel catheter cannulas provided in various sizes, shapes, and lengths for use during cardiovascular surgical procedures such as coronary artery bypass surgery. The cannulas are intended to be connected to a syringe filled with heparinized saline to confirm there is no leakage as well as ensure patency of harvested and/or grafted veins. The syringes are not being supplied with the cannulas nor are the syringes offered by Integra; therefore they are not part of this submission. These reusable devices are packaged non-sterile and are steam sterilizable.

The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.

Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures. The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.

The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

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The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire. The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient. The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula. The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

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The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip.