(88 days)
The Ultramax™ Woven Velour Vascular Graft is indicated for surgical repair, bypass or replacement of damaged vessels of the abdomen in cases of aneurysmal or occlusive disease.
Not Found
The provided document is an FDA 510(k) clearance letter for the Ultramax™ Woven Velour Vascular Graft. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.
This letter is a regulatory document stating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It refers to the "indications for use stated in the enclosure" and general controls provisions but does not elaborate on the specific technical performance or clinical study details that would typically be contained within the 510(k) submission itself.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.
§ 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.”