FDA product code · Cardiovascular
Endovascular Suturing System
7 FDA decisions since 2011. No recall names this code. The most-cited predicate is DEN100026, named by 5 later devices.
Provides fixation and sealing between and endovascular graft and the native artery.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OTD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · OTD
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OTD
Too few OTD 510(k)s in any year since 2007 to give a median.
Recalls per year · OTD
No recall names OTD since 2007.
Adverse event reports per year · OTD
53in 2025
MAUDE reports naming product code OTD, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 2 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 166 |
| 2017 | 1 | — | 0 | 161 |
| 2018 | 1 | — | 0 | 215 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 59 |
| 2022 | 0 | — | 0 | 52 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 62 |
| 2025 | 0 | — | 0 | 53 |
| 2026 | 0 | — | 0 | — |
Planning a device in OTD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report