510(k) · Decided
DecidedVascutek Vascusoft Plus Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbomedics, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Apr 25, 1996 as substantially equivalent to K910866 (Vascutek, Ltd., 1991) after a 64-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Apr 25, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910866 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910866 Vascusoft (VP1200K) Knitted Vascular ProsthesisVascutek, Ltd. · 1991
- This deviceK960706 Vascutek Vascusoft Plus Vascular GraftCarbomedics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910866 | Vascusoft (VP1200K) Knitted Vascular Prosthesis | Vascutek, Ltd. | 1991 | — |
| 0 (this device) | K960706 | Vascutek Vascusoft Plus Vascular Graft | Carbomedics, Inc. | 1996 | — |
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? (1)
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 |
|---|---|---|---|
| * | K910866 | Vascusoft (VP1200K) Knitted Vascular ProsthesisSummary page 1…, material (polyester), and function to the Vascutek Vascusoft™ Vascular Graft, which received 510(k) marketing clearance under K830016/F, later reassigned 510(k) number K910866 on April 1, 1991. @ PH:(512)435-3200 @ FAX(512)435-3350 @ WATS (800) 648-1579 (US AND CANADA) @ -7 - | 1991 |
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?
- Its one ancestor has no recall.
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.
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?
The Vascusoft™ Plus Vascular Graft is indicated for systemic vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960706: Vascutek Vascusoft Plus Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960706
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