510(k) · Cleared
Recalled · 2004Vascular Solutions Pronto Extraction Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Dec 19, 2003 after a 105-day review. The FDA summary names its predicate without a number. 3 of the 69 devices in its family, counting itself, have a Class I recall. 68 later devices descend from it. It has been recalled once.
- Decided
- Dec 19, 2003
- Review
- 105 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 0
68 later devices descend from it, 8 citing it directly. 3 of the 69 devices in this family, counting this one, have a Class I recall.
- This deviceK032763 Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2003
- Descendant · cites it directly · 59 of its ownK040869 Export CatheterMedtronic Vascular · 2004
- Descendant · 2 generations on · 30 of its ownK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- Descendant · cites it directly · 18 of its ownK042937 Modification to Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 17 of its ownK050276 Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · Recalled
- Descendant · cites it directly · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 68 · See all- K040869Export CatheterMedtronic Vascular · 2004 · cites it directly59descendants
- K061958Medtronic Export XT CatheterMedtronic Vascular · 2006 · 2 generations on30descendants
- K042937Modification to Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2005 · cites it directly18descendants
- K050276Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · cites it directly17descendants
- K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032763 | Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2003 | — |
| +1 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| +2 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| +1 | K042937 | Modification to Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| +1 | K050276 | Diver C.E. Catheter | Invatec Innovative Technologies, S.R.L. | 2005 | 1 |
| +1 | K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 | Kerberos Proximal Solutions, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 1 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 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? (3)
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 |
|---|---|---|---|
| * | — | Fogarty Thru-Lumen Embolectomy Catheter Named without a submission number | |
| * | — | American Biomed Embolectomy Catheter Named without a submission number | |
| * | — | LeMaitre Embolectomy Catheter Named without a submission number |
What descends from it? (68)
See all 688 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040869 | Export Catheter | 2004 | 59 |
| K042937 | Modification to Vascular Solutions Pronto Extraction Catheter | 2005 | 18 |
| K050276 | Diver C.E. Catheter | 2005 | 17 |
| K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 | 2004 | 17 |
| K050130 | Kerberos Proximal Solutions Rispiration System | 2005 | 16 |
| K051917 | Diver C.E. Catheter | 2005 | 13 |
| K053372 | Lbi Catheter System | 2006 | 10 |
| K060092 | Quickcat Extraction Catheter | 2006 | 2 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2004 | Not classified | Z-1089-04 | Other | The marker band in guidewire lumen could move from the manufactured location during clinical use. |
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.
- K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K040869 (Medtronic Vascular, 2004) has gone furthest, with 59 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.
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 | — |
What is it indicated for?
The Pronto™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
The Pronto™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
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/K032763 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032763: Vascular Solutions Pronto Extraction Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032763
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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