PMA · Approved
ApprovedLava Liquid Embolic System (Lava LES) and Lava Mixing Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirtex Medical, Inc. · QVG Embolization Agent, Vascular
Approved on Apr 4, 2023 through premarket approval, which rests on the device’s own clinical evidence after a 180-day review.
- Decided
- Apr 4, 2023
- Review
- 180 days
- Class
- Class III
- Product code
- QVG
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P220020 has 8 supplements since 2023: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QVG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QVG devicesQVG Embolization Agent, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVG
9so far in 2026, the most since 2007
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
MAUDE reports naming product code QVG, 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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 7 | — | 0 | 16 |
| 2026 | 9 | — | 0 | — |
https://510kreport.com/device/P220020 · printed Nov 6, 2026
Cite this page
510(k) Report. “P220020: Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P220020
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026