510(k) · Cleared
ClearedHemashield Woven Double Velour Vascular Graft Model M00202175XXXXX; M00202166XXXXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiovascular, LLC · MAL Graft, Vascular, Synthetic/Biologic Composite
Cleared on Sep 10, 2012 after a 14-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 10, 2012
- Review
- 14 days
- Class
- Class II
- Product code
- MAL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MAL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | HEMASHIELD Woven Vascular Grafts Named without a submission number |
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.
How does its category compare?
All MAL devicesMAL Graft, Vascular, Synthetic/Biologic Composite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MAL
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · MAL
Too few MAL 510(k)s in any year since 2007 to give a median.
Recalls per year · MAL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAL
27in 2025
MAUDE reports naming product code MAL, 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 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 3 | 7 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 0 | — | 0 | 20 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 0 | — | 0 | 24 |
| 2021 | 0 | — | 1 | 34 |
| 2022 | 0 | — | 1 | 21 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HEMASHIELD Vascular Grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122612: Hemashield Woven Double Velour Vascular Graft Model M00202175XXXXX; M00202166XXXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122612
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)
- Page last updated Nov 3, 2026