510(k) · Cleared
ClearedpVasc Net Mechanical Thrombectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Aug 5, 2026 as substantially equivalent to K201085 (Vesalio, 2021) after a 219-day review. Its family tree reaches back 6 generations to 1983. 3 of the 19 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 5, 2026
- Review
- 219 days
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K832023 (1983). 18 ancestors in all. No later device cites it as a predicate yet. 3 of the 19 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 deviceK254211 pVasc Net Mechanical Thrombectomy DeviceVesalio, Inc. · 2026
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) | K254211 | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | 2026 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K201085 | NeVa PV Thrombectomy DeviceSummary page 5…0 2. PRIMARY PREDICATE: Proprietary Name: NeVa PV Thrombectomy System Product Code: QEW, KRA 510(k) Number: K201085 1 510(K) SUMMARY… | 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 43 years and passes through 6 companies; a new generation was cleared every 7.4 years on median.
- 4 of the 18 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K201085.
What is it indicated for?
The pVasc Net Mechanical 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/K254211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254211: pVasc Net Mechanical 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/K254211
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026