510(k) · Cleared
ClearedMegaVac Mechanical Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capture Vascular, Inc. · QEX Coronary Mechanical Thrombectomy With Aspiration
Cleared on Aug 10, 2017 after an 80-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Aug 10, 2017
- Review
- 80 days
- Class
- Class II
- Product code
- QEX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK171493 MegaVac Mechanical Thrombectomy SystemCapture Vascular, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK182167 The ICHOR Panacea Vascular Embolectomy Catheter SystemIchor Vascular, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK223613 InThrill Thrombectomy SystemInari Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253407 NeVa PV Thrombectomy DeviceVesalio, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250421 InThrill™ Thrombectomy SystemInari Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233917 ICHOR 7F Embolectomy System (ICH-7F)Ichor · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182167The ICHOR Panacea Vascular Embolectomy Catheter SystemIchor Vascular, Inc. · 2018 · cites it directly2descendants
- K223613InThrill Thrombectomy SystemInari Medical, Inc. · 2023 · cites it directly1descendant
- K253407NeVa PV Thrombectomy DeviceVesalio, Inc. · 2025 · cites it directly0descendants
- K250421InThrill™ Thrombectomy SystemInari Medical, Inc. · 2025 · 2 generations on0descendants
- K233917ICHOR 7F Embolectomy System (ICH-7F)Ichor · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K171493 | MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. | 2017 | — |
| +1 | K182167 | The ICHOR Panacea Vascular Embolectomy Catheter System | Ichor Vascular, Inc. | 2018 | — |
| +1 | K223613 | InThrill Thrombectomy System | Inari Medical, Inc. | 2023 | — |
| +1 | K253407 | NeVa PV Thrombectomy Device | Vesalio, Inc. | 2025 | — |
| +2 | K250421 | InThrill™ Thrombectomy System | Inari Medical, Inc. | 2025 | — |
| +2 | K233917 | ICHOR 7F Embolectomy System (ICH-7F) | Ichor | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 QEX? 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 QEX device
- #1 K253407 NeVa PV Thrombectomy Devicescore 11.9 · 6 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (6)
3 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, K182167 (Ichor Vascular, Inc., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QEX devicesQEX Coronary Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · QEX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEX
Too few QEX 510(k)s in any year since 2007 to give a median.
Recalls per year · QEX
No recall names QEX since 2007.
Adverse event reports per year · QEX
23in 2025
MAUDE reports naming product code QEX, 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 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 81 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 1 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K171493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171493: MegaVac Mechanical Thrombectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171493
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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