510(k) · Cleared
ClearedLaguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Vascular, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Jun 1, 2023 as substantially equivalent to K211013 (Inari Medical, Inc., 2021) after a 153-day review. Its family tree reaches back 5 generations to 2018. 1 later device descends from it.
- Decided
- Jun 1, 2023
- Review
- 153 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K183198 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- 4 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 3 generations backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 2 generations backK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
- 1 generation backK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
- This deviceK223929 Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System…Innova Vascular, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK232730 Aventus Thrombectomy SystemInquis Medical · 2023
Most influential descendants
Showing 1 of 1 · See all- K232730Aventus Thrombectomy SystemInquis Medical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| −4 | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −3 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −2 | K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020 | — |
| −1 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16… | Inari Medical, Inc. | 2021 | — |
| 0 (this device) | K223929 | Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna… | Innova Vascular, Inc. | 2023 | — |
| +1 | K232730 | Aventus Thrombectomy System | Inquis Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20…Summary page 4…ion Medical Cardiovascular Specialty: Review Panel: Cardiovascular Predicate Device: FlowTriever Retrieval/Aspiration System (K211013) Device Description: The Laguna Clot Retriever™ System is a single use, sterile, non-pyrogenic medical device designed for use i… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232730 | Aventus Thrombectomy System | 2023 | 0 |
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.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232730 (Inquis Medical, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K211013.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The Laguna Thrombectomy System is indicated for:
* The non-surgical removal of emboli and thrombi from blood vessels.
* Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Laguna Thrombectomy System is intended for use in the peripheral vasculature.
The Malibu Aspiration Catheter™ System is indicated for:
* The non-surgical removal of emboli and thrombi from blood vessels.
* Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Malibu Aspiration Catheter™ System is intended for use in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223929 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223929: Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223929
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026