FDA product code · Cardiovascular
Intracardiac Patch Or Pledget, Biologically Derived
11 FDA decisions since 2017. 510(k) reviews decided 2021–2025 took a median of 195 days (half between 195 and 257). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K172085, named by 1 later device.
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PSQ 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 · PSQ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PSQ
73in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSQ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSQ
1in 2025
MAUDE reports naming product code PSQ, 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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 73 | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 2 | 4 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
Planning a device in PSQ? 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) ReportRelated product codes
Other codes under 21 CFR 870.3470.