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The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.

The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.

A surgical instrument used to occlude a blood vessel temporarily.

PICOCLAMP is Ethylene Oxide sterile single-use hemostasis clamp consisting of Polyetheretherketone (PEEK) and stainless steel (SUS series). PICOCLAMP is designed for use during surgery to temporarily occlude blood vessels during the anastomosis process. PICOCLAMP consists of three main direct patient-contacting parts, all of them are streilized; main body, axis, and spring. The body is consisting of two parts; the jaw which is used to occlude the blood vessel temporarily and the grip which functions to open and close jaws using the surgeon hand or the clamp forceps. The axis integrates the body and keep its parts intact. The spring functions to give clamping force to the jaws. Two types of clamps are provided: green color clamps used for arteries temporary occlusion and blue color clamps used for veins temporary occlusion. Both of the artery and vein clamp are having two types: single and double. PICOCLAMP is available in three different sizes; S (Small), M (Medium), and L (Large). PICOCLAMP is used for temporary occlusion of blood vessels with diameters ranging from 0.2mm to 2.0mm. The clipping power applied at the blood vessel differs depending on the size of the clamp and the pressure of the spring selected. Once the anastomosis process is complete, PICOCLAMP is removed from the patient.

The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is indicated for use to control bleeding in the pelvis, inguinal area, axilla and for pelvic fracture stabilization.

The AAJT-S device is a wedge-shaped bladder that when inflated pushes in on the body Over the target area of application. One of the target areas is the lower abdomen, over the umbilicus, compressing all the structures within, including the descending aorta, to achieve the physiological effects of aortic compression. The other two areas are over the inguinal region or the axilla. In these two areas the region is compressed with the wedge- shaped bladder including the major vasculature that runs through that area.

VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient. This modified version of VIOLA includes an ergonomic handle with operating button and a straight distal end. The VIOLA is comprised of: 1. A concentric 4 mm aortic punch with a detachable handle. 2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle. 3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision. The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.

Radial Artery Compression Tourniquets

GEM™ BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

The GEM™ Biover Microvascular Clamps (Clamps) are arterial and venous clamps in both single and double clamp configurations, available in varying sizes. The clamps are sterile, disposable clamps for single use. The clamps are used in microsurgery, plastic surgery, and hand surgery for the temporary occlusion of blood vessels during an anastomosis. The clamps are available for arteries and veins. The clamping force is higher for the arterial clamps than for the veinous clamps. The clamps are identified by a product reference code and by the color of the clamp. The clamps for veins are green, and the clamps for arteries are yellow. The clamps are packaged individually in two Tyvek pouches (double pouched). The devices in the Tyvek pouches are gamma sterilized and are placed in cartons of 10. The clamps are used once and are disposed of after use.

The TR Band® is a compression device indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).

The TR BAND® Radial Compression Device is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator. After a transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port. The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band. With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process. The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure or the brachial artery after a transbrachial procedure.

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The MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels during cardiovascular surgical procedures.

The MI DeTACH® is comprised of a Detachable Aortic Clamp Head and a Delivery System. The MI DeTACH® Detachable Aortic Cross Clamp Head is available in three sizes: Small, Medium, and Large (55mm, and 85mm enqagement pads respectively) which are packaged and distributed separately. The Delivery System is comprised of a Delivery Device and Quick Release Device. The Delivery Device is used to deliver, clamp, deploy, unclamp, and retrieve the Clamp Head from the target occlusion site. The MI DeTACH® Detachable Aortic Cross Clamp Head works by applying compression forces to the vessel by the padded device jaws. The top jaw is a pivot jaw allowing for parallel closure of the vessel during clamping. The amount of compression applied to the vessel for occlusion or partial occlusion is determined or adjusted by the means of the Delivery Device lever actuated jaw closure mechanism. The Clamp Head device contains ratchets that provide clamping tactile feedback to the user. A clutch mechanism prevents the user from applying excessive forces to the vessel by disengaging the lever from the device when specific force is obtained. Upon successfully clamping, the device locks and the handle is then detached leaving the clamp in the body throughout the duration of the procedure. The Delivery Device is then used to unclamp and remove the Clamp Head from the body upon procedure completion. In the event the Delivery Device becomes compromised during the course of a procedure, the Quick Release Device can be used to unclamp and remove the Clamp Head from the body.

The V. Mueller Cosgrove™ Flex Clamps are indicated to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.

Each V. Mueller Cosgrove™ Flex Clamp device consists of a ring handle, flexible shaft and jaw. The design of the flexible shaft allows the end user to bend the shaft following clamping of the blood vessel providing the user a clear field of visualization to the surgical site. The proposed device and the predicate device have a similar design, the same materials and the same manufacturing and fabrication methods/processes. The main difference between the subject device and the predicate device is a change to the wire configuration of the cable. In addition, the cleaning and sterilization instructions in the instructions for use were updated in accordance with current guidance. These changes do not raise different questions of safety or effectiveness.