510(k) · Cleared

Cleared

Export Catheter

K040869510(k) TraditionalCleared Jun 1, 200460-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

Medtronic Vascular · QEZ Aspiration Thrombectomy Catheter

Cleared on Jun 1, 2004 as substantially equivalent to K030201 (Medtronic Vascular, 2003) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 2001. 2 of the 66 devices in its family, counting itself, have a Class I recall. 59 later devices descend from it.

Decided: Jun 1, 2004
Review: 60 days
Class: Class II
Product code: QEZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K010579 (2001). 6 ancestors in all. 59 later devices descend from it, 6 citing it directly. 2 of the 66 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
1 generation backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
This deviceK040869 Export CatheterMedtronic Vascular · 2004
Descendant · cites it directly · 30 of its ownK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
Descendant · cites it directly · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
Descendant · cites it directly · 14 of its ownK050139 Modification to: Export CatheterMedtronic Vascular · 2005
Descendant · cites it directly · 12 of its ownK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
Descendant · 2 generations on · 11 of its ownK081573 Medtronic Export AP CatheterMedtronic Vascular · 2008

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2005high 8 (2008) · low 0 (2024)2026

Class I recalls in this family

K153485 ENROUTE Transcarotid Neuroprotection System5 generations on · 2016
K230402 ENROUTE® Transcarotid Neuroprotection System6 generations on · 2023

Most influential descendants

Showing 5 of 59 · See all

K061958Medtronic Export XT CatheterMedtronic Vascular · 2006 · cites it directly30descendants
K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · cites it directly16descendants
K050139Modification to: Export CatheterMedtronic Vascular · 2005 · cites it directly14descendants
K071727QXT Extraction CatheterVascular Solutions, Inc. · 2007 · cites it directly12descendants
K081573Medtronic Export AP CatheterMedtronic Vascular · 2008 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010579	Stent Support Guide Catheter	Medtronic Vascular	2001	27
−1	K030201	Modification to Export Aspiration Catheter	Medtronic Vascular	2003	—
0 (this device)	K040869	Export Catheter	Medtronic Vascular	2004	—
+1	K061958	Medtronic Export XT Catheter	Medtronic Vascular	2006	1
+1	K050130	Kerberos Proximal Solutions Rispiration System	Kerberos Proximal Solutions, Inc.	2005	—
+1	K050139	Modification to: Export Catheter	Medtronic Vascular	2005	—
+1	K071727	QXT Extraction Catheter	Vascular Solutions, Inc.	2007	—
+2	K081573	Medtronic Export AP Catheter	Medtronic Vascular	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	5	0
2007	6	0
2008	8	0
2009	5	0
2010	1	0
2011	2	0
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

FIG. 1 — Lineage of K040869, 2001–2026Source: 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.

2 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

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What was it cleared against? (2)

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
*	K030201	Modification to Export Aspiration Catheter Summary page 5 …77-0042 2. Classification Name: Embolectomy Catheter (21 CFR Part 870.5150) 3. Proprietary Name: Export Catheter 4. Name of Predicate Devices: Medtronic Export Catheter (K030201) Vascular Solutions Pronto Extraction Catheter (K032763) 5. Description: The Export Catheter is a dual lumen catheter for use wi…	Medtronic Vascular	2003	—
*	K032763	Vascular Solutions Pronto Extraction Catheter Summary page 5 …CFR Part 870.5150) 3. Proprietary Name: Export Catheter 4. Name of Predicate Devices: Medtronic Export Catheter (K030201) Vascular Solutions Pronto Extraction Catheter (K032763) 5. Description: The Export Catheter is a dual lumen catheter for use with the GuardWire Temporary Occlusion and Aspiration Syst…	Vascular Solutions, Inc.	2003	1

Also cleared against K030201: 1 other device →

What descends from it? (59)

See all 59

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

Number	Device	Applicant	Decided	Descendants
K061958	Medtronic Export XT Catheter	Medtronic Vascular	2006	30
K050130	Kerberos Proximal Solutions Rispiration System	Kerberos Proximal Solutions, Inc.	2005	16
K050139	Modification to: Export Catheter	Medtronic Vascular	2005	14
K071727	QXT Extraction Catheter	Vascular Solutions, Inc.	2007	12
K053372	Lbi Catheter System	Lumen Biomedical, Inc.	2006	10
K060092	Quickcat Extraction Catheter	Kensey Nash Corp.	2006	2

Has anything in its family been recalled? (2 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.

K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
2 of the 6 ancestors have a recall of any class.
Of its descendants, K061958 (Medtronic Vascular, 2006) has gone furthest, with 30 descendants of its own.
1 other device also cites its predicate K030201.

How does its category compare?

All QEZ devices

QEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Export Aspiration Catheter is indicated for:

Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and

To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.

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/K040869 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040869: Export Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040869

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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