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Advanta Graft (>6MM)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992960

by Atrium Medical Corp.

Identifiers

510(k) Number
K992960 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 Advanta Graft (>6MM) is a vascular graft prosthesis designed for use in arterial vascular reconstruction and segmental bypass procedures. It is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter under product code DSY, adhering to Class II regulatory standards with special controls.

This device is supplied sterile and intended for single-use in cardiovascular applications. It is regulated under FDA 510(k) clearance (K992960) and falls under the jurisdiction of the Cardiovascular Advisory Committee. The graft is manufactured by Atrium Medical Corp. and must be stored according to manufacturer instructions to maintain sterility and performance.

Frequently asked questions

What types of surgical procedures is the Advanta Graft (>6MM) intended for, and why is it specifically designed for arterial use?

The Advanta Graft (>6MM) is designed specifically for arterial vascular reconstruction and segmental bypass procedures, meaning it is used to replace or bypass damaged or blocked arteries. Its design as a vascular graft prosthesis with a diameter of 6mm or greater makes it suitable for larger-caliber arterial applications, where maintaining blood flow and structural integrity is critical. This distinguishes it from smaller-diameter grafts used in venous or microvascular applications.

Is the Advanta Graft (>6MM) reusable, or is it intended for single-use only? How does this affect its sterility and handling?

The Advanta Graft (>6MM) is intended for single-use only, as explicitly stated in its description. This design ensures sterility is maintained throughout its intended use, reducing the risk of infection or contamination. Since it is supplied sterile, it must be handled according to manufacturer instructions to preserve sterility until deployment, and any unused portion cannot be reused or reprocessed.

What storage instructions should be followed to ensure the Advanta Graft (>6MM) remains effective and sterile?

The device must be stored strictly according to the manufacturer’s instructions to maintain both sterility and performance. While the exact conditions aren’t detailed here, typical guidelines for sterile vascular grafts include keeping the graft in its sealed packaging, away from extreme temperatures, moisture, or direct sunlight. Improper storage could compromise its structural integrity or sterility, potentially affecting surgical outcomes.

How is the regulatory pathway for the Advanta Graft (>6MM) structured, and which committee oversees its submissions?

The Advanta Graft (>6MM) follows the FDA 510(k) clearance pathway, classified under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter) and regulated under Class II standards with special controls. Submissions are reviewed by the Cardiovascular (CV) Advisory Committee, which provides expert guidance on cardiovascular devices. The device holds clearance number K992960, issued on October 1, 1999, and is substantiated as *substantially equivalent* to a predicate device.

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 GRAFT (<6MM) by ATRIUM MEDICAL CORP. | FDA 510 (k) Summary, ADVANTA GRAFT (<6MM) (K992958) — FDA 510 (k) | Innolitics, K010517 - ADVANTA SST GRAFT (<6MM) | FDA 510 (k)

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) K992960 24 fields · synced Sep 19, 2026