510(k) · Cleared
ClearedNeVa PV Thrombectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesalio · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Jan 15, 2021 as substantially equivalent to K132281 (Codman & Shurtleff, Inc., 2013) after a 267-day review. Its family tree reaches back 5 generations to 1983. 3 of the 20 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jan 15, 2021
- Review
- 267 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K832023 (1983). 17 ancestors in all. 2 later devices descend from it, 2 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 4 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 3 generations backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- 2 generations backK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
- 1 generation backK132281 ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc. · 2013
- This deviceK201085 NeVa PV Thrombectomy DeviceVesalio · 2021
- Descendant · cites it directly · 0 of its ownK254211 pVasc Net Mechanical Thrombectomy DeviceVesalio, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253407 NeVa PV Thrombectomy DeviceVesalio, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −4 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −3 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| −2 | K092623 | F.a.S.T. System Sed and CXD | Genesis Medical Interventional, Inc. | 2009 | — |
| −1 | K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | Codman & Shurtleff, Inc. | 2013 | — |
| 0 (this device) | K201085 | NeVa PV Thrombectomy Device | Vesalio | 2021 | — |
| +1 | K254211 | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy DeviceSummary page 4…KRA – Catheter, Continuous Flush (21 CFR) §870.1210) Class: II PREDICATE DEVICE ReVive™ PV Thrombectomy Device (K132281) REFERENCE DEVICE Trevo Provue Thrombus Retriever (K122478) Solitaire Platinu… | 2013 |
| † | K122478 | Modified Trevo Retriever | 2012 |
| † | K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 38 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- 4 of the 17 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K254211 (Vesalio, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132281.
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. 2021, 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 NeVa™ PV Thrombectomy Device is indicated for:
The non-surgical removal of emboli and thrombi from peripheral blood vessels.
Temporary use in peripheral vessel occlusion.
Use with aspiration and with the injection or infusion of contrast media and other fluids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201085: NeVa PV Thrombectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201085
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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