510(k) · Cleared
ClearedFUSION Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiovascular, LLC · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Feb 16, 2016 as substantially equivalent to K131778 (Maquet Cardiovascular, LLC, 2013) and 1 other predicate after a 69-day review. Its family tree reaches back 5 generations to 1979.
- Decided
- Feb 16, 2016
- Review
- 69 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K791810 (1979). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
- 4 generations backK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
- 3 generations backK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
- 2 generations backK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
- 1 generation backK131778 Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2013 · Recalled
- This deviceK153523 FUSION Vascular GraftMaquet Cardiovascular, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K791810 | Vascular Graft Prost. of Expanded Ptfe | Impra, Inc. | 1979 | — |
| −4 | K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular… | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| −3 | K962433 | Meadox Exxcel Eptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
| −2 | K052964 | Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted… | Boston Scientific Corp | 2006 | 3 |
| −1 | K131778 | Fusion Vascular Graft and Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2013 | 1 |
| 0 (this device) | K153523 | FUSION Vascular Graft | Maquet Cardiovascular, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K131778 | Fusion Vascular Graft and Fusion Bioline Vascular GraftSummary page 4…Drug and Cosmetic Act, the device classification is Class II, Product code DSY. Predicate Devices: K131778 FUSION Vascular Grafts (SE: 14 November 2013) K962433 EXXCEL ePTFE Va… | 2013 |
| * | K962433 | Meadox Exxcel Eptfe Vascular GraftSummary page 4…Product code DSY. Predicate Devices: K131778 FUSION Vascular Grafts (SE: 14 November 2013) K962433 EXXCEL ePTFE Vascular Graft (SE: 1 April 1997) Device Description: FUSION Vascular Graft… | 1997 |
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?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K131778.
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. 2016, 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?
FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153523: FUSION 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/K153523
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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