510(k) · Cleared
ClearedJETi 88 Peripheral Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walk Vascular, LLC · QEZ Aspiration Thrombectomy Catheter
Cleared on Apr 17, 2019 after a 131-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Apr 17, 2019
- Review
- 131 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK183403 JETi 88 Peripheral Thrombectomy SystemWalk Vascular, LLC · 2019
- Descendant · cites it directly · 2 of its ownK201998 JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK213565 JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK232458 JETi™Hydrodynamic Thrombectomy SystemAbbott Medical · 2023
- Descendant · cites it directly · 0 of its ownK192439 JETi Peripheral Thrombectomy SystemWalk Vascular, LLC · 2019
Most influential descendants
Showing 4 of 4 · See all- K201998JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2020 · cites it directly2descendants
- K213565JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2022 · 2 generations on1descendant
- K232458JETi™Hydrodynamic Thrombectomy SystemAbbott Medical · 2023 · 3 generations on0descendants
- K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | 2019 | — |
| +1 | K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2020 | — |
| +2 | K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2022 | — |
| +3 | K232458 | JETi™Hydrodynamic Thrombectomy System | Abbott Medical | 2023 | — |
| +1 | K192439 | JETi Peripheral Thrombectomy System | Walk Vascular, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 QEZ? 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 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?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K201998 (Walk Vascular, LLC, 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
https://510kreport.com/device/K183403 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183403: JETi 88 Peripheral 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/K183403
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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