510(k) · Cleared
ClearedAdvanta VXT Vascular Graft, Flixene Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corporation · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Mar 28, 2024 as substantially equivalent to K992960 (Atrium Medical Corp., 1999) and 2 other predicates after a 269-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Mar 28, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K992960 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK992960 Advanta Graft (>6MM)Atrium Medical Corp. · 1999 · Recalled
- This deviceK231972 Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992960 | Advanta Graft (>6MM) | Atrium Medical Corp. | 1999 | 39 |
| 0 (this device) | K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
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 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992960 | Advanta Graft (>6MM)Summary page 6…10(k) Advanta VXT Vascular Graft Flixene Vascular Graft Predicate Device Information: The predicate devices are Atrium Medical Corporation , Advanta VXT Vascular Graft (K992960: October 01, 1999), Advanta VXT Vascular Graft (K992958: October 01, 1999) and Flixene Vascular Grafts (K071923: August 14, 2007)… | 1999 |
| * | K992958 | Advanta Graft (<6MM)Summary page 6…Predicate Device Information: The predicate devices are Atrium Medical Corporation , Advanta VXT Vascular Graft (K992960: October 01, 1999), Advanta VXT Vascular Graft (K992958: October 01, 1999) and Flixene Vascular Grafts (K071923: August 14, 2007). Advanta VXT is represented by two (2) predicate… | 1999 |
| * | K071923 | Ptfe Flixene Graduated Wall GraftSummary page 6…Atrium Medical Corporation , Advanta VXT Vascular Graft (K992960: October 01, 1999), Advanta VXT Vascular Graft (K992958: October 01, 1999) and Flixene Vascular Grafts (K071923: August 14, 2007). Advanta VXT is represented by two (2) predicate in this submission as K992958 (Product Code: DY… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 3 of the 3 ancestors have a recall of any class.
How does its category compare?
All DSY devicesDSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSY
160in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSY
151in 2025
MAUDE reports naming product code DSY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 120 |
| 2008 | 1 | — | 0 | 164 |
| 2009 | 5 | 73 | 2 | 193 |
| 2010 | 4 | 55 | 5 | 187 |
| 2011 | 1 | — | 0 | 165 |
| 2012 | 4 | 30 | 0 | 177 |
| 2013 | 5 | 69 | 1 | 207 |
| 2014 | 2 | — | 0 | 352 |
| 2015 | 1 | — | 0 | 460 |
| 2016 | 1 | — | 2 | 217 |
| 2017 | 3 | 269 | 0 | 193 |
| 2018 | 1 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 232 |
| 2020 | 1 | — | 0 | 169 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 155 |
| 2023 | 2 | — | 0 | 149 |
| 2024 | 5 | 160 | 0 | 153 |
| 2025 | 2 | — | 1 | 151 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231972: Advanta VXT Vascular Graft, Flixene Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231972
Report an extraction error
Are you the manufacturer?
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