510(k) · Cleared
ClearedVascutek Gelweave Vascular Graft (Bifurcated Configuration)
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 Feb 19, 1997 as substantially equivalent to K952293 (Vascutek, Ltd., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Feb 19, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952293 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952293 Vascutek Gelweave Vascular GraftVascutek, Ltd. · 1995
- This deviceK964665 Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK162794 Gelweave Vascular GraftsVascutek, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK241550 Gelweave™ Vascular ProsthesesVascutek, Ltd. · 2025 · Recalled
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 |
|---|---|---|---|---|---|
| −1 | K952293 | Vascutek Gelweave Vascular Graft | Vascutek, Ltd. | 1995 | — |
| 0 (this device) | K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration) | Carbomedics, Inc. | 1997 | — |
| +1 | K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017 | — |
| +2 | K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K952293 | Vascutek Gelweave Vascular GraftSummary page 1…and substantially equivalent in intended use, composition, and function to the straight configuration which received marketing clearance on December 19, 1995 510(k) via K952293. Common name of the device: Prosthesis, Vascular Graft Trade or Proprietary name: Vascutek Gelweave™ vascular graft (bifurcated… | 1995 |
| † | P890045 | Gelseal TM Triaxial Vascular Graft | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162794 | Gelweave Vascular Grafts | 2017 | 1 |
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?
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 Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
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/K964665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964665: Vascutek Gelweave Vascular Graft (Bifurcated Configuration).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964665
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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