Search Results

The Evolution® Mechanical Dilator Sheath Set, Evolution® Shortie Mechanical Dilator Sheath Set, SteadySheath™ Evolution® Tissue Stabilization Sheath, and SteadySheath™ Evolution® Shortie Tissue Stabilization Sheath are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Evolution® Mechanical Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9, 11, and 13 French diameters) is designed to rotate in a clockwise manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters. The Evolution® Shortie Mechanical Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in clockwise manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 13.6 centimeters. The SteadySheath™ Evolution® Tissue Stabilization Sheath and SteadySheath™ Evolution® Shortie Tissue Stabilization Sheath are designed to be used in place of the standard outer sheath that is supplied as part of the Evolution family of mechanical/controlled-rotation dilator sheath sets. They are provided for use in situations where better sheath tip visibility and/or tissue stabilization is desired. In its role as an Evolution outer sheath, the SteadySheath™ works in concert with the inner Evolution braided inner sheath to assist in the removal of cardiac leads or related catheters by bypassing and/or disrupting transvenous binding scar tissue. The SteadySheath™ has a highly radiopaque, textured stainless steel tip that helps stabilize tissue so that better binding scar tissue control and disruption can be achieved.

The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Evolution® RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9. 11. and 13 French diameters) is designed to rotate in either a uni-rotational or bi-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters. The Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in in either a uni-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The devices have a working length of 13.6 centimeters.

The Cook Vascular Blood Flow Monitor - Model DP-M350 is intended for monitoring blood flow in vessels intraoperatively, and following micro-vascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for one-time use.

The proposed device is monitor unit that generates a (20 MHz) signal and conducts it to an attached probe that contains a piezo-electric crystal which transmits and then receives Doppler frequency sound waves. The returning signal is amplified and projected via the proposed monitoring unit as an audible output. The monitor unit has two input channels and also provides an adjunct visible (LED) indicator that is used as a complimentary information source to the primary audible indicator. The predicate device was submitted as a system, the proposed device is only the monitoring unit.

The devices are for use in patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec using media with a maximum viscosity of 11.8 cP.

The proposed device is exactly the same as the predicate devices.

The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The proposed device is a polypropylene dilator with a semi-threaded stainless steel tip, This stainless steel tip is used to dilate tissue surrounding an indwelling catheter or foreign object. In addition, an ergonomic handle to be used as a "drive mechanism" will be included. The device will be made with 7.0 and 9.0 French sizes. It will be supplied sterile, intended for one-time use.

The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory to the Cook Vascular PERFECTA™ Electrosurgical Dissection System. The intended use of the Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is to add the option of continuous or intermittent activation to the Electrosurgical Dissection System when the footswitch is depressed. The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is supplied nonsterile and is reusable.

The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory that can be used with the Cook Vascular PERFECTA™ Electrosurgical Dissection System. This device adds the option to automatically activate the Valley(ab Force FX electrosurgical generator at a predetermined rate when the footswitch is depressed.

The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use

The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.

The COOK- Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers. The COOK-Swartz Doppler Flow Probe is supplied sterile and intended for one time use

The Modified COOK-Swartz Doppler Flow Probe is intended for monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures. The COOK-Swartz Doppler Flow Probe is supplied sterile, and nonpyroqenic and is intended for one-time use. Reasonable assurance of biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing.