510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Advanta Graft (>6MM)

K992960510(k) SpecialCleared Oct 1, 199929-day reviewClass II21 CFR 870.3450Recalls 39

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Atrium Medical Corp. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on Oct 1, 1999 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 39 times.

Decided
Oct 1, 1999
Review
29 days
Class
Class II
Product code
DSY
Recalls
39
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992960 Advanta Graft (>6MM)Atrium Medical Corp. · 1999
  2. Descendant · cites it directly · 0 of its ownK231972 Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992960Advanta Graft (>6MM)Atrium Medical Corp.1999—
+1K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K992960, 1999–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DSY device

  1. #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation20240

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 3, 2024Class IIZ-1970-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1979-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1966-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1968-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1985-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1959-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1973-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1989-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1983-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1984-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1955-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1952-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1967-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1972-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1991-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1981-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1961-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1977-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1975-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1980-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1986-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1960-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1987-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1971-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1990-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1992-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1969-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1988-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1976-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1957-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1965-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1974-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1963-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1982-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1953-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1978-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
May 3, 2024Class IIZ-1956-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Aug 25, 2021Class IIZ-2589-2021Under Investigation by firmThe product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Jul 12, 2013Class IIZ-2304-2013Package design/selectionInner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field

The 5 latest of 39 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K231972 (Atrium Medical Corporation, 2024) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DSY devices

DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSY

2in 2025

2007: 12008: 12009: 52010: 42011: 12012: 42013: 52014: 22015: 12016: 12017: 32018: 12019: 12020: 12021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 5 (2009) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSY

160in 2024

2009: 73 days median2010: 55 days median2012: 30 days median2013: 69 days median2017: 269 days median2024: 160 days median
2007high 269 (2017) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSY

1in 2025

2009: 22010: 52013: 12016: 22025: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSY

151in 2025

2007: 1202008: 1642009: 1932010: 1872011: 1652012: 1772013: 2072014: 3522015: 4602016: 2172017: 1932018: 2002019: 2322020: 1692021: 1682022: 1552023: 1492024: 1532025: 151
2007high 460 (2015) · low 120 (2007)2025

MAUDE reports naming product code DSY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0120
20081—0164
20095732193
20104555187
20111—0165
20124300177
20135691207
20142—0352
20151—0460
20161—2217
201732690193
20181—0200
20191—0232
20201—0169
20212—0168
20222—0155
20232—0149
202451600153
20252—1151
20261—1—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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Recent decisions in DSY

The DSY category page

  • K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
  • K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025
  • K241550Gelweave™ Vascular ProsthesesVascutek, Ltd. · 20251 recall
  • K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 20241 recall
  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024

https://510kreport.com/device/K992960 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992960: Advanta Graft (>6MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992960

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026