510(k) · Cleared
Recalled · Class II · 2023Fusion Vascular Graft and Fusion Bioline 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 Nov 14, 2013 as substantially equivalent to K962433 (Meadox Medicals, Div. Boston Scientific Corp., 1997) and 2 other predicates after a 150-day review. Its family tree reaches back 4 generations to 1979. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 14, 2013
- Review
- 150 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K791810 (1979). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
- 3 generations backK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
- 2 generations backK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
- 1 generation backK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
- This deviceK131778 Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2013
- Descendant · cites it directly · 0 of its ownK252445 Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
- Descendant · cites it directly · 0 of its ownK153523 FUSION Vascular GraftMaquet Cardiovascular, LLC · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K791810 | Vascular Graft Prost. of Expanded Ptfe | Impra, Inc. | 1979 | — |
| −3 | K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular… | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| −2 | K962433 | Meadox Exxcel Eptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
| −1 | K052964 | Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted… | Boston Scientific Corp | 2006 | 3 |
| 0 (this device) | K131778 | Fusion Vascular Graft and Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2013 | — |
| +1 | K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K962433 | Meadox Exxcel Eptfe Vascular GraftSummary page 1…ular Grafts Common Name: Vascular Graft Classification Name: Vascular Graft Prosthesis Predicate Device: EXXCEL h Soft ePTFIE Vascular Grafts (K962433, K052964 and K1 13101) Device Description: FUSIONTh Vascular Grafts are synthetic vascular grafts… | 1997 |
| * | K052964 | Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Summary page 1…ts Common Name: Vascular Graft Classification Name: Vascular Graft Prosthesis Predicate Device: EXXCEL h Soft ePTFIE Vascular Grafts (K962433, K052964 and K1 13101) Device Description: FUSIONTh Vascular Grafts are synthetic vascular grafts… | 2006 |
| * | K113101 | Exxcel Soft Eptee Vascular Graft-Standard Wall,Thin WallSummary page 1…Graft Classification Name: Vascular Graft Prosthesis Predicate Device: EXXCEL h Soft ePTFIE Vascular Grafts (K962433, K052964 and K1 13101) Device Description: FUSIONTh Vascular Grafts are synthetic vascular grafts constructed of two la… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2023 | Class II | Z-1245-2023 | Process control | One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K252445 (Maquet Cardiovascular, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K962433.
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. 2013, 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™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131778: Fusion Vascular Graft and Fusion Bioline 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/K131778
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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