Search Results

The Bi-Directional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.

The Bi-Directional Tunneler is a stainless steel device composed of a knurled handle, shafts in different lengths and curvatures, bullet tips from 4mm to 12 mm diameter, and a vein tip with a luer adapter. Each tunneler shaft is manufactured with internal threaded ends and a locking mechanism on each end for interchangeable tip and handle attachment. Each tip is manufactured with an external threaded end for luer adapter and shaft attachment. The Bi-Directional Tunneler is supplied non-sterile to the user in a stainless steel perforated case. The perforations are intended to facilitate steam sterilization.

Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.

Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.

IMPRA High Porosity Grafts are indicated for use as vascular prosthesis for bypass or reconstruction of peripheral arterial blood vessels.

The IMPRA High Porosity Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a high porosity construction.

The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

The IMPRA ePTFE Arteriovenous Cuffed Graft is indicated for use as a subcutaneous arteriovenous conduit for blood access.

The IMPRA ePTFE Arteriovenous Cuffed Graft is an expanded polytetrafluoroethylene angioaccess graft [i.e., an IMPRA ePTFE Vascular Graft, the predicate device for this 510(k)] with a modified venous end. The venous end is cuffed, facilitating vessel conformity, a uniform suturing surface, and improved flow through the anastomosis. The IMPRA ePTFE Arteriovenous Cuffed Graft is made from the same materials as the predicate device, i.e., polytetrafluoroethylene (PTFE), lubricant used as a manufacturing aid, a blue pigment used in the orientation lines, and the external support PTFE beading. These grafts are supplied in the same product configurations as the predicate device (straight, stepped, CenterFlex, and stepped CenterFlex), and are packaged, labeled, and sterilized in the same manner as the predicate device.

The IMPRA ePTFE Arteriovenous Cuffed Graft is indicated for use as a subcutaneous arteriovenous conduit for blood access.

The IMPRA ePTFE Arteriovenous Cuffed Graft is an expanded polytetrafluoroethylene angioaccess graft [i.e., an IMPRA ePTFE Vascular Graft, the predicate device for this 510(k)] with a modified venous end. The venous end is cuffed, facilitating vessel conformity, a uniform suturing surface, and improved flow through the anastomosis. The IMPRA ePTFE Arteriovenous Cuffed Graft is made from the same materials as the predicate device, i.e., polytetrafluoroethylene (PTFE), lubricant used as a manufacturing aid, a blue pigment used in the orientation lines, and the external support PTFE beading. These grafts are supplied in the same product configurations as the predicate device (straight, stepped, CenterFlex, and stepped CenterFlex), and are packaged, labeled, and sterilized in the same manner as the predicate device.