510(k) · Cleared

Recalled · 2006

5F Medtronic Launcher Guide Catheter

K030779510(k) SpecialCleared Apr 24, 200344-day reviewClass II21 CFR 870.1250Recalls 7

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 Apr 24, 2003 as substantially equivalent to K021256 (Medtronic Vascular, 2002) and 1 other predicate after a 44-day review. Its family tree reaches back 2 generations to 1998. 1 of the 14 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 7 times.

Decided: Apr 24, 2003
Review: 44 days
Class: Class II
Product code: DQY
Recalls: 7
Predicates: 2

Its longest line of descent runs back 2 generations to K981198 (1998). 3 ancestors in all. 10 later devices descend from it, 4 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
1 generation backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
This deviceK030779 5F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003
Descendant · cites it directly · 2 of its ownK140034 Surefire Guiding CatheterSurefire Medical, Inc. · 2014
Descendant · cites it directly · 2 of its ownK120585 Convey Guiding CatheterPendracare International, B.V. · 2012
Descendant · cites it directly · 2 of its ownK062420 5F Sherpa Active NX Guide CatheterMedtronic Vascular · 2006
Descendant · cites it directly · 1 of its ownK103386 Medtronic Vascular - Hub Material Modification to the 5F and 8F…Medtronic, Inc. · 2011 · Recalled
Descendant · 2 generations on · 0 of its ownK250972 Primum Hydrophilic Guiding CatheterPendracare · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 2 (2013) · low 0 (2007)2026

Class I recalls in this family

K132673 5F & 6F Launcher Guide Catheter, 5F Sherpa…2 generations on · 2013

Most influential descendants

Showing 5 of 10 · See all

K140034Surefire Guiding CatheterSurefire Medical, Inc. · 2014 · cites it directly2descendants
K120585Convey Guiding CatheterPendracare International, B.V. · 2012 · cites it directly2descendants
K0624205F Sherpa Active NX Guide CatheterMedtronic Vascular · 2006 · cites it directly2descendants
K103386Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide…Medtronic, Inc. · 2011 · cites it directly1descendant
K250972Primum Hydrophilic Guiding CatheterPendracare · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K981198	Medtronic Zuma Guiding Catheter	Medtronics Interventional Vascular	1998	25
−1	K021256	Z3 Guide Catheter	Medtronic Vascular	2002	52
0 (this device)	K030779	5F Medtronic Launcher Guide Catheter	Medtronic Vascular	2003	—
+1	K140034	Surefire Guiding Catheter	Surefire Medical, Inc.	2014	—
+1	K120585	Convey Guiding Catheter	Pendracare International, B.V.	2012	—
+1	K062420	5F Sherpa Active NX Guide Catheter	Medtronic Vascular	2006	—
+1	K103386	Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R)…	Medtronic, Inc.	2011	1
+2	K250972	Primum Hydrophilic Guiding Catheter	Pendracare	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2011	1	0
2012	1	0
2013	2	1
2014	2	0
2016	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K030779, 1998–2025Source: 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.

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 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? (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
*	K021256	Z3 Guide Catheter	Medtronic Vascular	2002	52
*	K010579	Stent Support Guide Catheter	Medtronic Vascular	2001	27

Also cleared against K021256: 6 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K140034	Surefire Guiding Catheter	Surefire Medical, Inc.	2014	2
K120585	Convey Guiding Catheter	Pendracare International, B.V.	2012	2
K062420	5F Sherpa Active NX Guide Catheter	Medtronic Vascular	2006	2
K103386	Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide…	Medtronic, Inc.	2011	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 5, 2006	Not classified	Z-0930-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0932-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0933-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0934-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0936-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0931-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0935-06	Other	Potential for non-sterility due to loss of package integrity

The 5 latest of 7 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

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
3 of the 3 ancestors have a recall of any class.
Of its descendants, K140034 (Surefire Medical, Inc., 2014) has gone furthest, with 2 descendants of its own.
6 other devices also cite its predicate K021256.

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)	—

What is it indicated for?

The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030779 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030779: 5F Medtronic Launcher Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030779

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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