Hemashield Vantage Vascular Graft

• • Terminated Z-1459-05 FDA Unclassified (pre-2012) ·initiated 27 Jun 2005

  During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.

510(k) Number

K961847 ↗

FDA Product Code

DSY

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

ST

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  Class III

  FDA 510(k) K760443 Active Cleared 26 Aug 1976

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  FDA 510(k) K962433 Active Cleared 17 Mar 1997

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  FDA 510(k) K943358 Active Cleared 2 Jun 1995

• Hemashield Microvel Velour Knitted Vascular Graft

  Class II

  FDA 510(k) K954848 Active Cleared 1 Feb 1996

See all devices from Meadox Medicals, Div. Boston Scientific Corp. →

• What types of vascular procedures is the Hemashield Vantage Vascular Graft specifically designed for?

  The Hemashield Vantage Vascular Graft is designed for systemic vascular reconstructions, particularly in peripheral vascular applications. It is intended for use in replacing diseased sections of blood vessels, such as those affected by aneurysmal or occlusive disease, where a graft with a diameter of 6 mm or greater is required.

• Is the Hemashield Vantage Vascular Graft intended for reuse, or is it meant to be used only once?

  The Hemashield Vantage Vascular Graft is explicitly intended for single-use only, as stated in its design and regulatory documentation. This ensures patient safety and sterility standards are maintained.

• How is the Hemashield Vantage Vascular Graft supplied, and what does this mean for handling?

  The Hemashield Vantage Vascular Graft is supplied sterile, meaning it is pre-sterilized and packaged to prevent contamination before use. This allows for immediate use upon opening, provided proper sterile technique is followed during handling and implantation.

• What regulatory pathway was followed for the approval of the Hemashield Vantage Vascular Graft?

  The Hemashield Vantage Vascular Graft received FDA clearance through a 510(k) submission, specifically under the traditional review pathway. It was determined to be substantially equivalent to predicate devices and falls under FDA regulation number 870.3450, classified as a Class II medical device. The device is also tracked for post-market surveillance.

• Are there multiple sizes or configurations available for the Hemashield Vantage Vascular Graft, and how are they tracked?

  Yes, the Hemashield Vantage Vascular Graft comes in multiple sizes and configurations, each with its own registration number (e.g., 1721676, 1018233, etc.). These variations are tracked individually under the FDA’s post-market surveillance system to ensure ongoing safety and performance monitoring.