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Advanta Super Soft Graft

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000499

by Atrium Medical Corp.

Identifiers

510(k) Number
K000499 FDA 510(k)
FDA Product Code
DSY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3450 FDA 510(k)
Regulation Number
870.3450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a vascular graft prosthesis intended to repair, replace, repair, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is classified as a prosthesis, vascular graft, of 6mm and greater diameter.

It is supplied as a sterile, single-use device for implantation in cardiovascular procedures. The device has received FDA 510(k) clearance under K000499 and is regulated as a Class II medical device with product code DSY.

Frequently asked questions

What is the ADVANTA SUPER SOFT GRAFT used for?

The ADVANTA SUPER SOFT GRAFT is a vascular graft prosthesis intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is designed for use in cardiovascular procedures where a conduit of 6mm or greater diameter is needed to restore blood flow.

How is the ADVANTA SUPER SOFT GRAFT supplied and is it reusable?

The device is supplied as a sterile, single-use device for implantation. It is intended for one-time use only and must not be resterilized or reused, as doing so could compromise its structural integrity, increase infection risk, and violate its regulatory clearance conditions.

What sizes or models of the ADVANTA SUPER SOFT GRAFT are available?

The device is classified as a vascular graft of 6mm and greater diameter. While the data confirms this size threshold, specific length or diameter variations within this range are not detailed in the provided information. Users should consult the product labeling or manufacturer’s catalog for available size options.

What regulatory pathway was used for the ADVANTA SUPER SOFT GRAFT?

The device received FDA 510(k) clearance under submission number K000499, which determined it to be substantially equivalent to a legally marketed predicate device. It is regulated as a Class II medical device with product code DSY, reflecting its classification as a prosthesis, vascular graft, of 6mm and greater diameter.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ADVANTA SUPER SOFT GRAFT by ATRIUM MEDICAL CORP. | FDA 510 (k) Summary, K000504 - ADVANTA SUPER SOFT GRAFT | FDA 510 (k), ADVANTA SUPER SOFT GRAFT 510 (k) K000499 - FDA.report, PDF K000504 ADVANTA SUPER SOFT GRAFT - 510kdatabase.net, ADVANTA SUPER SOFT GRAFT (K000504) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atrium Medical Corp.

Sources (1)

  • FDA 510(k) K000499 24 fields · synced Sep 21, 2026