(83 days)
InterGard Woven collagen coated vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
InterGard Woven Collagen Coated Vascular Prostheses
This document is a 510(k) clearance letter from the FDA for a medical device called "InterGard Woven Collagen Coated Vascular Prostheses." It declares the device substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot provide the requested information based on the input text. The document is strictly a regulatory clearance and does not delve into the technical validation of the device.
§ 870.3450 Vascular graft prosthesis.
(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.”