510(k) · Cleared
ClearedPronto V3 Extraction Catheter, Model 5003
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 14, 2006 as substantially equivalent to K052232 (Vascular Solutions, Inc., 2005) after a 36-day review. Its family tree reaches back 1 generation to 2005. 1 of the 29 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it.
- Decided
- Dec 14, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052232 (2005). 27 later devices descend from it, 8 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK052232 Vascular Solutions Pronto V3 Extraction CatheterVascular Solutions, Inc. · 2005
- This deviceK063371 Pronto V3 Extraction Catheter, Model 5003Vascular Solutions, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · 2 generations on · 4 of its ownK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K101354 Fetch 2 Aspiration Catheter Model 109400-0013 generations on · 2011
Most influential descendants
Showing 5 of 27 · See all- K071727QXT Extraction CatheterVascular Solutions, Inc. · 2007 · cites it directly12descendants
- K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007 · cites it directly11descendants
- K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc. · 2009 · cites it directly10descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · cites it directly5descendants
- K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc. · 2010 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052232 | Vascular Solutions Pronto V3 Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| 0 (this device) | K063371 | Pronto V3 Extraction Catheter, Model 5003 | Vascular Solutions, Inc. | 2006 | — |
| +1 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| +1 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| +1 | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| +1 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +2 | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K052232 | Vascular Solutions Pronto V3 Extraction CatheterSummary page 5…6-4228 Fax 763-656-4253 Pronto™ V3 Extraction Catheter Embolectomy catheter I Embolectomy catheter (21CFR870.5150, Product Code DXE) Pronto™ V3 Extraction Catheter (K052232), manufactured by Vascular Solutions, Inc. Device Description The Pronto V3 extraction catheter is a dual lumen polymeric cathe… | 2005 |
What descends from it? (27)
See all 278 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071727 | QXT Extraction Catheter | 2007 | 12 |
| K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | 2007 | 11 |
| K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010… | 2009 | 10 |
| K113757 | Aspire Max Aspiration Catheter | 2012 | 5 |
| K100569 | Merit Embolectomy Catheter Model ASAP100 | 2011 | 2 |
| K070363 | Fetch Aspiration Catheter | 2007 | 2 |
| K131998 | Aspire RX-LP6 Aspiration Catheter | 2013 | 1 |
| K073627 | Flexor Evac Aspiration Catheter | 2008 | 0 |
Has anything in its family been recalled? (1 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.
- K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 catheter is indicated for the removal of fresh, soft emboli and thrombi from
vessels in the coronary and peripheral vasculature.
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/K063371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063371: Pronto V3 Extraction Catheter, Model 5003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063371
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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