(a)Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.
(b)Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Guidance Document for Vascular Prostheses 510(k) Submissions."
[66 FR 18542, Apr. 10, 2001]