510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Advanta Graft (<6MM)

K992958510(k) SpecialCleared Oct 1, 199929-day reviewClass II21 CFR 870.3450Recalls 15

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

Atrium Medical Corp. · DYF Prosthesis, Vascular Graft, Of Less Then 6mm 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 15 times.

Decided
Oct 1, 1999
Review
29 days
Class
Class II
Product code
DYF
Recalls
15
Predicates
0

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

Descendants, by year cleared 2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992958 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)K992958Advanta 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 K992958, 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 DYF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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-1954-2024Equipment 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-1999-2024Equipment 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-1993-2024Equipment 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-1995-2024Equipment 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-1996-2024Equipment 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-1994-2024Equipment 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-1997-2024Equipment 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-1951-2024Equipment 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-2001-2024Equipment 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-1958-2024Equipment 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-2000-2024Equipment 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-1964-2024Equipment 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-1962-2024Equipment 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-1998-2024Equipment maintenanceComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Jul 12, 2013Class IIZ-2313-2013Package 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 15 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 DYF devices

DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYF

FDA has decided no DYF device since 2007.

Median 510(k) review, days · DYF

Too few DYF 510(k)s in any year since 2007 to give a median.

Recalls per year · DYF

No recall names DYF since 2007.

Adverse event reports per year · DYF

3in 2025

2007: 52008: 42009: 22010: 62011: 92012: 22013: 162014: 72015: 122016: 352017: 182018: 62019: 52020: 72021: 52022: 92023: 82024: 62025: 3
2007high 35 (2016) · low 2 (2009)2025

MAUDE reports naming product code DYF, 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
20070—05
20080—04
20090—02
20100—06
20110—09
20120—02
20130—016
20140—07
20150—012
20160—035
20170—018
20180—06
20190—05
20200—07
20210—05
20220—09
20230—08
20240—06
20250—03
20260—0—

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.

More from Atrium Medical Corp.

75 FDA decisions under this applicant name. See the company

  • P120003/S007iCast Covered Stent SystemAtrium Medical Corp. · 2026
  • P120003/S009iCast Covered Stent SystemAtrium Medical Corp. · 2025
  • P120003/S011iCast Covered Stent SystemAtrium Medical Corp. · 2025
  • P120003/S010iCast Covered Stent SystemAtrium Medical Corp. · 2025
  • P120003/S006iCast Covered Stent SystemAtrium Medical Corp. · 2025

Recent decisions in DYF

The DYF category page

  • K004012Impra Carboflo Eptfe Vascular GraftsImpra, Inc. · 2001
  • K000504Advanta Super Soft GraftAtrium Medical Corp. · 20001 recall
  • K991683Ptfe Ringed Gore-Tex Vascular GraftW. L. Gore & Associates, Inc. · 1999
  • K992441Advanta GraftAtrium Medical Corp. · 19991 recall
  • K984183Perma-Pass Vascular Graft, 5T Graft,Model 31451Possis Medical, Inc. · 1999

https://510kreport.com/device/K992958 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992958: Advanta Graft (<6MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992958

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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