PMA · Approved
ApprovedMicrovel (R) with Hemashield
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
Approved on Apr 26, 1989 through premarket approval, which rests on the device’s own clinical evidence after a 1,763-day review. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Apr 26, 1989
- Review
- 1,763 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceP840029 Microvel (R) with HemashieldMaquet Cardiovascular, LLC · 1989
- Descendant · cites it directly · 2 of its ownK954848 Hemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996 · Recalled
- Descendant · 2 generations on · 0 of its ownK103080 Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK961847 Hemashield Vantage (Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · Recalled
Class I recalls in this family
- K103080 Albograft Vascular Prosthesis2 generations on · 2011
Most influential descendants
Showing 3 of 3 · See all- K954848Hemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996 · cites it directly2descendants
- K103080Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 2011 · 2 generations on0descendants
- K961847Hemashield Vantage (Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K103080 | Albograft Vascular Prosthesis | LeMaitre Vascular, Inc. | 2011 | Class I |
| +2 | K961847 | Hemashield Vantage (Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2011 | 1 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K954848 | Hemashield Microvel Velour Knitted Vascular Graft | 1996 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K103080Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 117 Class I recalls
What does this lineage say?
- Of its descendants, K954848 (Meadox Medicals, Div. Boston Scientific Corp., 1996) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/P840029 · printed Nov 4, 2026
Cite this page
510(k) Report. “P840029: Microvel (R) with Hemashield.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P840029
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026