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K Number
K202471
Device Name
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
Manufacturer
PECA Labs
Date Cleared
2020-12-11

(105 days)

Product Code
DSY
Regulation Number
870.3450
Type
Traditional
Panel
CV
Reference & Predicate Devices
K183613,K013250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.

exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Device Description

The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.

AI/ML Overview

This document is a 510(k) summary for a medical device (exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft) and therefore does not contain information about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/ML powered device. The information provided is for a traditional medical device (vascular graft) and focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing.

Therefore, I cannot provide the requested information.

§ 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.”