Search Results

Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures. The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter. The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system. The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap. The insertion tool is used to facilitate placement of a guide wire tip through the Y connector. The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.

The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

The Galt Medical Attachable Cath Lab Hemostasis Valve assembly consists of a molded hub with an integrated hemostasis valve, sideport tubing with 3 way stopcock. The design of the Attachable Cath Lab Hemostasis Valve is derived directly from the current line of Galt Medical Cath Lab Introducer Sheath (K043525). The subject and predicate device are both have an integrated hemostasis valve, and side port tubing with stopcock.

The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.

The Passage Hemostasis Valve minimizes blood loss during diagnostic and interventional procedures. The Merit Passage Hemostasis Valve consists of a Y-adaptor with a hemostasis valve which also incorporates a female luer lock connector and a male luer lock rotator. The polycarbonate used to manufacture the adaptor is transparent to aid in visualizing entrapped air. The hemostatic valve adjusts between 0 to 0.097" (approximately 7 French). The Y-body design allows both injection of contrast and placement of interventional devices. The Passage Hemostasis Valve is comprised of a stand-alone rotator assembly bonded to the polycarbonate Y-body, using a UV cured adhesive. The seal and washer are inserted into the Y-body valve port. A thin coat of silicone is applied to the threaded portion of the Y-body and the cap is assembled. The standalone rotator assembly is comprised of individually molded polycarbonate parts(housing connector, retaining collar, hub) and an EPDM(Ethylene Propylene Diene Monomer) O-Ring.

Merit's Rotating Adapters are indicated for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Merit's Rotating Adapters are marketed in two configurations: Male-Male Adapter (MMA) and Male-Female Adapter (MFA). The adapters are comprised of a stand-alone rotator assembly bonded to a polycarbonate male or female luer lock, using a UV cured adhesive. The stand-alone rotator assembly is comprised of individually molded polycarbonate parts (housing connector, retaining collar, hub) and an

CoLign™ The Hemostasis Valve is intended to to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French or smaller. The insertion tool facilitates introduction of the guide wire go through the hemostasis valve. The torquer when inserted into the proximal end of the guide wire provides a handle for easier manipulation of the guide wire.

The CoLign Hemostasis Valve is a device that can be operated with only one hand through its special "push-pull" mechanism. In the pushed-down position, the valve is open for safe insertion and removal of devices. In the pulled-up position, the valve is closed and seals smoothly round the inserted devices. Once the valve is closed, devices can still be manipulated freely. CoLign eliminates the need for adjustment of the hemostasis valve by rotating during the procedure. The CoLign Hemostasis Valve is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the CoLign Hemostasis Valve: the Standard CoLign , the CoLign 20,and the CoLign 50. The configuration of the sideport is the only difference among the three models. The sideport of the Standard CoLign ends in a male luer, while the sidearm of the CoLign 20/50 ends with a 20/50 cm extension tubing and 3-way stopcock.

Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

The flexible luer lock adapters are single use only devices that consist of a flexible tubing segment with an inner diameter of 0.32 cm (0.125 in) with a male luer adapter on one end and a female luer adapter on the other end. This device is currently packaged with the Affinity Pixie Cardiotomy/Venous Reservoir device. It is also available as a standalone device (subject of this submission).

Medtronic Connector Components with Balance™ Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect tubing and the primary devices of the bypass circuit. The lumen of the Connector Components with Balance Biosurface consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The Connector Components with Balance Biosurface are comprised of polycarbonate and Balance Biosurface materials and provided in Ytype, straight, reducer and adapter (luer) configurations.

Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures. The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the lowpressure seal and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/ interventional device in position within the vasculature and allows for pressure injections up to 600 psi (40 ATM). A guidewire introducer and guidewire torque device may be included with the Guardian II NC hemostasis valves.

The Mediane Stopcock and Manifold are indicated to serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.

Medline Stopcock and Manifold

The E-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French. The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter. The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

The E-Pass is a unique one-hand operated, "push-pull" hemostatic valve system. It consists of two pieces of silicone hemostasis valve. The quick open-close valve reduces the patient blood loss significantly during endovascular procedures. In the push forward position the valves is 100% open for safe insertion and removal of devices. In the pulled back position the valve is 100% closed and seals smoothly around the inserted devices. Once the valve is closed, devices can still be manipulated freely. E-Pass eliminates the need for rotating hemostatic valve adjustments during the procedure. The E-Pass hemostatic valve system is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the E-Pass: the standard E-Pass and the E-Pass20/E-Pass50. The configuration of the sideport is the only difference among the three models. The sideport of the standard E-Pass ends in a female luer, while the sidearm of the E-Pass 20/ 50ends with a 20/50 cm extension tubing and 3-way stopcock.