510(k) · Cleared

Recalled · 2011

Stent Support Guide Catheter

K010579510(k) TraditionalCleared Nov 21, 2001267-day reviewClass II21 CFR 870.1250Recalls 27

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

Medtronic Vascular · DQY Catheter, Percutaneous

Cleared on Nov 21, 2001 after a 267-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 87 devices in its family, counting itself, have a Class I recall. 86 later devices descend from it. It has been recalled 27 times.

Decided: Nov 21, 2001
Review: 267 days
Class: Class II
Product code: DQY
Recalls: 27
Predicates: 0

86 later devices descend from it, 3 citing it directly. 5 of the 87 devices in this family, counting this one, have a Class I recall.

This deviceK010579 Stent Support Guide CatheterMedtronic Vascular · 2001
Descendant · cites it directly · 60 of its ownK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
Descendant · 2 generations on · 59 of its ownK040869 Export CatheterMedtronic Vascular · 2004
Descendant · 3 generations on · 30 of its ownK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
Descendant · cites it directly · 24 of its ownK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
Descendant · 3 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2002high 8 (2008) · low 0 (2024)2026

Class I recalls in this family

K132673 5F & 6F Launcher Guide Catheter, 5F Sherpa…2 generations on · 2013
K042489 6F Z4 Guide Catheter2 generations on · 2004
K083422 6F Taiga Guiding Catheter3 generations on · 2009
K153485 ENROUTE Transcarotid Neuroprotection System5 generations on · 2016

Most influential descendants

Showing 5 of 86 · See all

K030201Modification to Export Aspiration CatheterMedtronic Vascular · 2003 · cites it directly60descendants
K040869Export CatheterMedtronic Vascular · 2004 · 2 generations on59descendants
K061958Medtronic Export XT CatheterMedtronic Vascular · 2006 · 3 generations on30descendants
K021256Z3 Guide CatheterMedtronic Vascular · 2002 · cites it directly24descendants
K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 3 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010579	Stent Support Guide Catheter	Medtronic Vascular	2001	—
+1	K030201	Modification to Export Aspiration Catheter	Medtronic Vascular	2003	—
+2	K040869	Export Catheter	Medtronic Vascular	2004	—
+3	K061958	Medtronic Export XT Catheter	Medtronic Vascular	2006	1
+1	K021256	Z3 Guide Catheter	Medtronic Vascular	2002	52
+3	K050130	Kerberos Proximal Solutions Rispiration System	Kerberos Proximal Solutions, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	3	0
2004	2	1
2005	3	0
2006	7	0
2007	6	0
2008	8	0
2009	6	1
2010	2	0
2011	3	0
2012	5	0
2013	5	1
2014	3	0
2015	2	0
2016	4	1
2017	5	0
2018	2	0
2019	2	0
2020	3	0
2021	2	0
2022	1	0
2023	5	1
2025	2	0
2026	2	0

FIG. 1 — Lineage of K010579, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

5 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (86)

See all 86

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

Number	Device	Applicant	Decided	Descendants
K030201	Modification to Export Aspiration Catheter	Medtronic Vascular	2003	60
K021256	Z3 Guide Catheter	Medtronic Vascular	2002	24
K030779	5F Medtronic Launcher Guide Catheter	Medtronic Vascular	2003	10

Has anything in its family been recalled? (5 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 8, 2011	Not classified	Z-2754-2011	Labeling Change Control	Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve
Apr 5, 2006	Not classified	Z-1014-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1015-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1016-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1026-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1027-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1028-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1029-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1030-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1031-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1036-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1037-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1023-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1024-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1035-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1017-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1021-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1025-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1038-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1039-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1018-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1020-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1022-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1032-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1033-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1034-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1040-06	Other	Potential for non-sterility due to loss of package integrity

The 5 latest of 27 recalls; the web page lists all.

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.

K1326735F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding CatheterMedtronic, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 1191 Class I recalls
K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 1191 Class I recalls
K0834226F Taiga Guiding CatheterMedtronic Vascular · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
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?

Of its descendants, K030201 (Medtronic Vascular, 2003) has gone furthest, with 60 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

https://510kreport.com/device/K010579 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010579: Stent Support Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010579

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026