510(k) · Cleared
ClearedVascutek Cobrahood Eptfe Vascular Grafts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascutek, Ltd. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Aug 31, 2009 as substantially equivalent to K041528 (Vascutek, Ltd., 2004) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Aug 31, 2009
- Review
- 75 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983861 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK983861 Distaflo Bypass GraftImpra, Inc. · 1998 · Recalled
- This deviceK091778 Vascutek Cobrahood Eptfe Vascular GraftsVascutek, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983861 | Distaflo Bypass Graft | Impra, Inc. | 1998 | 2 |
| 0 (this device) | K091778 | Vascutek Cobrahood Eptfe Vascular Grafts | Vascutek, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K041528 | Modification to Eptfe GraftSummary page 2…Qiia 510k Vascutek: MAIFl TM:WLrap Grafts ePTFE wrapped ePTFE vascular grafts * 14 September. 2004 K041528 NOTE: '?PTFE external support cleared under K043552 on 5 1h January 2005 for wrapped grafts (K041528)… | 2004 |
| * | K983861 | Distaflo Bypass GraftSummary page 2…IMP RA Inc. DistafBlo:Bypass Grafts ePTFE wrapped ePTFE vascular grafts t 2 4 h November 1998 K983861 with flared distal end Device Description: Vascuteks ePTFE vascular grafts were originally cleared by FDA in 199'9… | 1998 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K041528.
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. 2009, 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?
Bypass Or reconstruction of peripheral arterial blood vessels
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091778 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091778: Vascutek Cobrahood Eptfe Vascular Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091778
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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