(9 days)
CREATION OF SUBCUTANEOUS ARTERIOVENOUS CONDUITS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.
ePTFE vascular prosthesis (unsealed and gelatin sealed)
This document is a 510(k) clearance letter from the FDA for a medical device, specifically an ePTFE vascular prosthesis. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has similar indications for use, technological characteristics, and can be marketed subject to general controls.
Therefore, I cannot extract the requested information from the provided text. The document is about regulatory clearance, not a performance study.
§ 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.”