510(k) · Cleared

Cleared

Pronto .035 Extraction Catheter

K070403510(k) TraditionalCleared Jun 13, 2007121-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vascular Solutions, Inc. · QEZ Aspiration Thrombectomy Catheter

Cleared on Jun 13, 2007 as substantially equivalent to K051193 (Vascular Solutions, Inc., 2005) and 2 other predicates after a 121-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it.

Decided: Jun 13, 2007
Review: 121 days
Class: Class II
Product code: QEZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K970657 (1997). 3 ancestors in all. 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK970657 Lmi Thrombectomy CatheterLucas Medical, Inc. · 1997
This deviceK070403 Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007
Descendant · cites it directly · 6 of its ownK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
Descendant · 2 generations on · 5 of its ownK192814 Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020
Descendant · 3 generations on · 4 of its ownK211492 Pounce Thrombectomy SystemSurmodics,Inc. · 2021
Descendant · 4 generations on · 3 of its ownK220501 Pounce Thrombectomy SystemSurmodics,Inc. · 2022
Descendant · 5 generations on · 2 of its ownK231022 Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 10 · See all

K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011 · cites it directly6descendants
K192814Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020 · 2 generations on5descendants
K211492Pounce Thrombectomy SystemSurmodics,Inc. · 2021 · 3 generations on4descendants
K220501Pounce Thrombectomy SystemSurmodics,Inc. · 2022 · 4 generations on3descendants
K231022Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970657	Lmi Thrombectomy Catheter	Lucas Medical, Inc.	1997	—
0 (this device)	K070403	Pronto .035 Extraction Catheter	Vascular Solutions, Inc.	2007	—
+1	K110315	Nexgen Peripheral Mechanical Retrieval Device	Nexgen Medical Systems, Inc.	2011	—
+2	K192814	Pounce Thrombus Retrieval System	Surmodics,Inc.	2020	—
+3	K211492	Pounce Thrombectomy System	Surmodics,Inc.	2021	—
+4	K220501	Pounce Thrombectomy System	Surmodics,Inc.	2022	—
+5	K231022	Pounce™ Thrombectomy System	Surmodics,Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2017	1	0
2018	1	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K070403, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in QEZ? 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

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K051193	Vascular Solutions Pronto Short Extraction Catheter Summary page 5 …fication Name: Embolectomy Catheter Product Code: DXE Regulation: Class II, 21 CFR 870.5150 Predicate Device(s) Vascular Solutions Pronto™ Short Extraction Catheter (K051193) Lucas Medical, Inc. Thrombectomy Catheter (K970657) Edwards Lifesciences Fogarty Venous Thrombectomy Catheter (510k unknown) Le…	Vascular Solutions, Inc.	2005	1
*	K970657	Lmi Thrombectomy Catheter Summary page 5 …XE Regulation: Class II, 21 CFR 870.5150 Predicate Device(s) Vascular Solutions Pronto™ Short Extraction Catheter (K051193) Lucas Medical, Inc. Thrombectomy Catheter (K970657) Edwards Lifesciences Fogarty Venous Thrombectomy Catheter (510k unknown) LeMaitre Vascular Inc. (formerly Vascutech, Inc.) LeMa…	Lucas Medical, Inc.	1997	—
*	K992934	Lemaitre Venous Thrombectomy Catheter Summary page 5 …70657) Edwards Lifesciences Fogarty Venous Thrombectomy Catheter (510k unknown) LeMaitre Vascular Inc. (formerly Vascutech, Inc.) LeMaitre Venous Thrombectomy Catheter (K992934) Device Description The Pronto .035” extraction catheter is a dual lumen, over-the-wire (OTW) catheter with relat…	Vascutech, Inc.	2000	—
*	—	Edwards Lifesciences Fogarty Venous Thrombectomy Catheter Named without a submission number			—

Also cleared against K051193: 3 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110315	Nexgen Peripheral Mechanical Retrieval Device	Nexgen Medical Systems, Inc.	2011	6
K112571	XL Extraction Catheter	Vascular Solutions, Inc.	2011	2

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K110315 (Nexgen Medical Systems, Inc., 2011) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K051193.

How does its category compare?

All QEZ devices

QEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · QEZ

5in 2025

2007high 11 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEZ

108in 2025

2007high 144 (2013) · low 33 (2010)2026

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

2007high 21 (2025) · low 0 (2007)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	MAUDE reports
2007	11	79	0
2008	6	72	0
2009	4	83	0
2010	3	33	0
2011	7	118	0
2012	5	90	0
2013	4	144	0
2014	1	—	0
2015	0	—	0
2016	1	—	0
2017	3	112	0
2018	1	—	0
2019	3	94	0
2020	3	120	0
2021	3	53	2
2022	2	—	18
2023	1	—	14
2024	1	—	17
2025	5	108	21
2026	6	98	—

What is it indicated for?

The Pronto .035” extraction catheter is indicated for:

The removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system.

The removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system.

To infuse/deliver diagnostic or therapeutic agents.

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/K070403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070403: Pronto .035 Extraction Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070403

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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