510(k) · Cleared
Recalled · 2005Hemashield Vantage (Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meadox Medicals, Div. Boston Scientific Corp. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Jan 22, 1997 as substantially equivalent to K954848 (Meadox Medicals, Div. Boston Scientific Corp., 1996) after a 254-day review. Its family tree reaches back 2 generations to 1989. It has been recalled once.
- Decided
- Jan 22, 1997
- Review
- 254 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to P840029 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backP840029 Microvel (R) with HemashieldMaquet Cardiovascular, LLC · 1989
- 1 generation backK954848 Hemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996 · Recalled
- This deviceK961847 Hemashield Vantage (Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P840029 | Microvel (R) with Hemashield | Maquet Cardiovascular, LLC | 1989 | — |
| −1 | K954848 | Hemashield Microvel Velour Knitted Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | 6 |
| 0 (this device) | K961847 | Hemashield Vantage (Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
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 12.5 · 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 |
|---|---|---|---|
| * | K954848 | Hemashield Microvel Velour Knitted Vascular GraftSummary page 1…ascular Grafts HEMASHIELD® CARDIOVASCULAR GRAFTS: HEMASHIELD® MICROVEL® Double Velour Knitted Vascular Grafts HEMASHIELD® Woven Double Velour Vascular Grafts [510(k) #K954848, determined substantially equivalent Feb. 1, 1996) The HEMASHIELD VANTAGE™ Vascular Graft is a woven polyester graft, impregnate… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2005 | Not classified | Z-1459-05 | Other | During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K954848.
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?
For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region.
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/K961847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961847: Hemashield Vantage (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/K961847
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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