FDA product code · Cardiovascular

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Name: FDA decisions, review times, recalls and adverse event reports for product code OOB
Creator: 510(k) Report

OOBClass IIIPMA required2 decisions since 20240 recalls

2 FDA decisions since 2024. No recall names this code.

A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of OOB 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 · OOB

4so far in 2026, the most since 2007

2007high 4 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OOB

Too few OOB 510(k)s in any year since 2007 to give a median.

Recalls per year · OOB

No recall names OOB since 2007.

Adverse event reports per year · OOB

225in 2025

2007high 225 (2025) · low 0 (2007)2025

MAUDE reports naming product code OOB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	3	—	141
2025	3	—	225
2026	4	—	—

FIG. 1 — OOB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OOB? 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

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

What has FDA decided in OOB lately?