510(k) · Cleared
Recalled · 2011Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath
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 22, 2010 as substantially equivalent to K083784 (Vascular Solutions, Inc., 2009) after a 33-day review. Its family tree reaches back 6 generations to 2001. 1 of the 26 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 2010
- Review
- 33 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010579 (2001). 21 ancestors in all, the oldest K883718 (1989). 4 later devices descend from it, 1 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 5 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 4 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 3 generations backK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- 2 generations backK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- 1 generation backK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- This deviceK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK161506 Penumbra Aspiration SystemPenumbra, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK163618 INDIGO Aspiration SystemPenumbra, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK180412 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine…Penumbra, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK220683 INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc. · 2022
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…2 generations back · 2006
Most influential descendants
Showing 4 of 4 · See all- K161506Penumbra Aspiration SystemPenumbra, Inc. · 2016 · cites it directly3descendants
- K163618INDIGO Aspiration SystemPenumbra, Inc. · 2017 · 2 generations on2descendants
- K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc. · 2018 · 3 generations on1descendant
- K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −5 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −4 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −3 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| −2 | 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 | — |
| 0 (this device) | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | — |
| +1 | K161506 | Penumbra Aspiration System | Penumbra, Inc. | 2016 | — |
| +2 | K163618 | INDIGO Aspiration System | Penumbra, Inc. | 2017 | — |
| +3 | K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and… | Penumbra, Inc. | 2018 | — |
| +4 | K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | Penumbra, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Summary page 5…Name Extraction catheter · Classification Name 21 CFR 870.5150, Embolectomy Catheter Predicate Devke Pronto V3 extraction catheter (K083784 - Vascular Solutions, Inc.} Device Description The Pronto V4 extraction catheter (Pronto) is a dual lumen rapid exchange cat… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161506 | Penumbra Aspiration System | 2016 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2011 | Not classified | Z-2946-2011 | Process control | Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This may cause injury… |
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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K161506 (Penumbra, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K083784.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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/K103405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103405: Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103405
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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