FDA product code · Cardiovascular

Occluder, Balloon, Vena-Cava

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

LWTClass IIIPMA required1 decision since 19770 recalls

1 FDA decision since 1977. No recall names this code.

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 LWT 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 · LWT

FDA has decided no LWT device since 2007.

Median 510(k) review, days · LWT

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

Recalls per year · LWT

No recall names LWT since 2007.

Adverse event reports per year · LWT

No MAUDE report names LWT since 2007.

View these four charts as a table

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

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

Planning a device in LWT? 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

Occluder, Balloon, Vena-Cava

What has FDA decided in LWT lately?