510(k) Report

FDA product code · Cardiovascular

Embolization Agent, Vascular

QVGClass IIIPMA required2 decisions since 20230 recalls

2 FDA decisions since 2023. No recall names this code.

For occluding peripheral vessels

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 QVG 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 · QVG

9so far in 2026, the most since 2007

2023: 32024: 12025: 72026 (partial year): 9
2007high 9 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QVG

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

Recalls per year · QVG

No recall names QVG since 2007.

Adverse event reports per year · QVG

16in 2025

2024: 22025: 16
2007high 16 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20233—00
20241—02
20257—016
20269—0—
FIG. 1 — QVG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QVG? 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