Dialysis grafts

SealPTFE

by Vascutek Ltd

An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).

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SealPTFE models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
S40S06CRSHLumen/Inner Diameter 6 mm; Length 40 cm Not statedAvailable

Procedures that use dialysis grafts

Frequently asked questions

What is SealPTFE used for?

An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).

Who makes SealPTFE?

SealPTFE is made by Vascutek Ltd. It is listed under dialysis grafts (av grafts and hero) in our device library.

What sizes does SealPTFE come in?

Sizes listed for SealPTFE: Lumen/Inner Diameter: 6 mm; Length: 40 cm. Confirm availability with the manufacturer's instructions for use.

Is SealPTFE MRI safe?

The FDA device database entry for SealPTFE does not state its MRI safety status. Check the labeling before MRI.

Is SealPTFE FDA cleared?

SealPTFE is registered in the FDA's Global Unique Device Identification Database (GUDID).

How do I contact a Vascutek Ltd sales representative?

Vascutek Ltd has not listed representatives on LA Vascular yet. Visit the Vascutek Ltd company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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