FDA product code · Neurology

Balloon, Detachable, For Neurovascular Occlusion

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

MZQClass II21 CFR 882.5950510(k) required2 decisions since 19980 recalls

2 FDA decisions since 1998. 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, neurology panel

Twenty years of MZQ 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 · MZQ

FDA has decided no MZQ device since 2007.

Median 510(k) review, days · MZQ

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

Recalls per year · MZQ

No recall names MZQ since 2007.

Adverse event reports per year · MZQ

1in 2011

2007high 1 (2009) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	1
2010	—	0
2011	—	1
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 — MZQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MZQ? 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

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Other codes under 21 CFR 882.5950.

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Balloon, Detachable, For Neurovascular Occlusion

Which MZQ devices have the deepest lineage?

What has FDA decided in MZQ lately?

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