(26 days)
InterGard Knitted Ultra Thin Vascular Graft
- InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the 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.
HemaCarotid Patch Ultra Thin
The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.
InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches
This document is a 510(k) clearance letter from the FDA, which declares substantial equivalence for the InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical trial report or a performance study would.
Therefore, I cannot provide the requested information based on the provided text, as this document type typically does not include the details of performance studies or acceptance criteria tables. The FDA 510(k) clearance process relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive new performance studies in all cases.
§ 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.”