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The Wilson-Cook® Colonic Z-Stent® is a self-expanding, tubular prosthesis used to maintain patency of malignant colonic strictures in patients having high operative risk and/or advanced disease. The Wilson-Cook® Colonic Z-Stent® Introduction System is used to place the Colonic Z-Stent®. This device and the introduction system are supplied sterile and intended for single use only.

The Wilson-Cook® Colonic Z-Stent® is a self-expanding, tubular prosthesis used to maintain patency of malignant colonic strictures in patients having high operative risk and/or advanced disease. The Wilson-Cook® Colonic Z-Stent® Introduction System is used to place the Colonic Z-Stent®. This device and the introduction system are supplied sterile and intended for single use only.

The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy sampling sampling.

The Mini Polyurethane Catheter is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the Mini Polyurethane Catheter are identical to those used in predicate Vital-Port® system catheters. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing.

The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects. The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.

The devices consist of sheaths and snares intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and foreign objects and/or in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.

The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive microvascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for onetime use.

The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive 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 device is supplied sterile and is intended for one-Reasonable assurance of biocompatibility of time use. the materials comprising the Swartz Doppler Flow Probe is provided by their established history of use in medical product manufacturing.

The Vital-Port® Infusion Pal™ is intended to facilitate locating and stabilizing the port body for accessing the portal septum of a Vital-Port® Vascular Access System.

The Vital-Port® Infusion Pal™ is an open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body for accessing Vital-Port® Vascular Access Systems. The Vital-Port® Infusion Pal™ is placed on the skin surface on the area overlying the port septum. The device is supplied sterile and intended for onetime use.

The TARGET Vital-Port® Vascular Access System is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

The TARGET Vital-Port® Vascular Access System is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the TARGET Vital-Port® Vascular Access System are identical to those used in predicate Vital-Port® systems. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing. Totally implantable vascular access systems consist of a port reservoir or chamber with an attached catheter. The port reservoir is covered by a self-sealing silicone rubber septum through which fluids are administered or withdrawn. The attached catheter is surgically placed in the targeted vessel and the port reservoir is implanted under the skin; the system is accessed using a non-coring needle.

intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects.

The Flexible Dilating Sheath is intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Flexible Dilating Sheath is provided by their established history of use in medical product manufacturing. Results of toxicity testing also provide reasonable assurance of biocompatibility, with the results showing the material to meet the test requirements