510(k) · Cleared
Recalled · Class II · 2013Advanta Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corp. · DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Cleared on Aug 20, 1999 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Aug 20, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- DYF
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYF? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Jul 12, 2013 | Class II | Z-2309-2013 | Package design/selection | Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DYF devicesDYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYF
FDA has decided no DYF device since 2007.
Median 510(k) review, days · DYF
Too few DYF 510(k)s in any year since 2007 to give a median.
Recalls per year · DYF
No recall names DYF since 2007.
Adverse event reports per year · DYF
3in 2025
MAUDE reports naming product code DYF, 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 | 5 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Atrium Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ Graft use in aortocronary bypass applications or for use as a patch.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992441 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992441: Advanta Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992441
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026