510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Atrium Flixene Graft

K060124510(k) SpecialCleared Mar 30, 200671-day reviewClass II21 CFR 870.3450Recalls 18

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 Mar 30, 2006 after a 71-day review. The FDA summary names no predicate by number. It has been recalled 18 times.

Decided
Mar 30, 2006
Review
71 days
Class
Class II
Product code
DSY
Recalls
18
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K060124Source: FDA 510(k) database · 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 summary (predicates and 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 12.5 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 3, 2024Class IIZ-2003-2024Equipment 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-2010-2024Equipment 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-2015-2024Equipment 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-2012-2024Equipment 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-2009-2024Equipment 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-2002-2024Equipment 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-2006-2024Equipment 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-2013-2024Equipment 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-2007-2024Equipment 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-2008-2024Equipment 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-2014-2024Equipment 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-2011-2024Equipment 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-2004-2024Equipment 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-2018-2024Equipment 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-2005-2024Equipment 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-2017-2024Equipment 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-2016-2024Equipment 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-2310-2013Package 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 18 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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 Flixene 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 Flixene Graft use in aortocoronary bypass applications or for

use as a patch.

Indications for use as stated in the FDA summary.

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 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/K060124 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060124: Atrium Flixene Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060124

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