FDA product code · Cardiovascular
Stent, Coronary
21 FDA decisions since 1993. 21 recalls name this code, 0 of them Class I. The most-cited predicate is P900043/
The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MAF 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 · MAF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAF
Too few MAF 510(k)s in any year since 2007 to give a median.
Recalls per year · MAF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAF
111in 2025
MAUDE reports naming product code MAF, 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 | 34 | — | 1 | 1,201 |
| 2008 | 41 | — | 1 | 1,288 |
| 2009 | 36 | — | 5 | 1,370 |
| 2010 | 55 | — | 0 | 1,568 |
| 2011 | 67 | — | 0 | 1,233 |
| 2012 | 77 | — | 0 | 1,053 |
| 2013 | 41 | — | 0 | 1,049 |
| 2014 | 53 | — | 0 | 876 |
| 2015 | 22 | — | 0 | 664 |
| 2016 | 26 | — | 0 | 696 |
| 2017 | 35 | — | 0 | 695 |
| 2018 | 32 | — | 0 | 675 |
| 2019 | 25 | — | 1 | 561 |
| 2020 | 21 | — | 0 | 430 |
| 2021 | 13 | — | 0 | 329 |
| 2022 | 8 | — | 0 | 280 |
| 2023 | 8 | — | 0 | 207 |
| 2024 | 3 | — | 0 | 219 |
| 2025 | 2 | — | 0 | 111 |
| 2026 | 4 | — | 0 | — |
Planning a device in MAF? 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