510(k) · Decided
DecidedNeVa PV Thrombectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesalio, Inc. · QEX Coronary Mechanical Thrombectomy With Aspiration
Cleared on Nov 24, 2025 as substantially equivalent to K171493 (Capture Vascular, Inc., 2017) and 1 other predicate after a 55-day review. Its family tree reaches back 6 generations to 1983. 3 of the 20 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 24, 2025
- Review
- 55 days
- Class
- Class II
- Product code
- QEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K832023 (1983). 19 ancestors in all. No later device cites it as a predicate yet. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 5 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 4 generations backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- 3 generations backK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
- 2 generations backK132281 ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc. · 2013
- 1 generation backK201085 NeVa PV Thrombectomy DeviceVesalio · 2021
- This deviceK253407 NeVa PV Thrombectomy DeviceVesalio, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −5 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −4 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| −3 | K092623 | F.a.S.T. System Sed and CXD | Genesis Medical Interventional, Inc. | 2009 | — |
| −2 | K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | Codman & Shurtleff, Inc. | 2013 | — |
| −1 | K201085 | NeVa PV Thrombectomy Device | Vesalio | 2021 | — |
| 0 (this device) | K253407 | NeVa PV Thrombectomy Device | Vesalio, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 1 |
| 1998 | 4 | 1 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2017 | 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.
3 devices in this family have a Class I recall. 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K171493 | MegaVac Mechanical Thrombectomy SystemSummary page 5…CFR 870.5150 Primary Predicate: Proprietary Name: MegaVac Mechanical Thrombectomy System Product Code: QEX 510(k) Number: K171493 Secondary Predicate Proprietary Name: NeVa PV Thrombectomy Device Product Code: QEW, KRA 510(k) Nu… | 2017 |
| * | K201085 | NeVa PV Thrombectomy DeviceSummary page 5…K171493 Secondary Predicate Proprietary Name: NeVa PV Thrombectomy Device Product Code: QEW, KRA 510(k) Number: K201085 1… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 42 years and passes through 6 companies; a new generation was cleared every 7.4 years on median.
- 4 of the 19 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K171493.
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. 2025, 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 | — |
What is it indicated for?
The NeVa PV Thrombectomy Device is indicated for:
• The non-surgical removal of thrombus burden from coronary blood vessels,
• Use with adjunctive aspiration and with the injection or infusion of contrast media and other fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253407: NeVa PV Thrombectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253407
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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