# K992960: Advanta Graft (>6MM) - Pathway: 510(k) (Special) - Applicant: Atrium Medical Corp. - Decided: Oct 1, 1999 after 29 days - Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter) - Device class: 2 - Regulation: 21 CFR 870.3450 - Recalls of this device: 39 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 1 later device descends from it; 1 cites it directly. 0 of 2 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. FDA’s file for it is a 510(k) statement, which names no predicate. ## Most influential descendants - K231972: Advanta VXT Vascular Graft, Flixene Vascular Graft (2024), 0 descendants of its own ## Recalls of this device - May 3, 2024 · Class II · Z-1970-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1979-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1966-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1968-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1985-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1959-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1973-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1989-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1983-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1984-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1955-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1952-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1967-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1972-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1991-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1981-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1961-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1977-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1975-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1980-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1986-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1960-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1987-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1971-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1990-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1992-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1969-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1988-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1976-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1957-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1965-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1974-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1963-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1982-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1953-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1978-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - May 3, 2024 · Class II · Z-1956-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. - Aug 25, 2021 · Class II · Z-2589-2021: The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. - Jul 12, 2013 · Class II · Z-2304-2013: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field ## Indications for use The Atrium (Wrapped) Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch. Source page: https://510kreport.com/device/K992960 Methodology: https://510kreport.com/methodology