510(k) · Cleared

Recalled · Class II · 2021

Z3 Guide Catheter

K021256510(k) SpecialCleared May 17, 200228-day reviewClass II21 CFR 870.1250Recalls 52

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 May 17, 2002 as substantially equivalent to K981198 (Medtronics Interventional Vascular, 1998) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1998. 3 of the 27 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it. It has been recalled 52 times.

Decided: May 17, 2002
Review: 28 days
Class: Class II
Product code: DQY
Recalls: 52
Predicates: 2

Its longest line of descent runs back 1 generation to K981198 (1998). 2 ancestors in all. 24 later devices descend from it, 7 citing it directly. 3 of the 27 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
This deviceK021256 Z3 Guide CatheterMedtronic Vascular · 2002
Descendant · cites it directly · 11 of its ownK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
Descendant · cites it directly · 10 of its ownK030779 5F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003 · Recalled
Descendant · cites it directly · 8 of its ownK042489 6F Z4 Guide CatheterMedtronic Vascular · 2004 · Recalled (Class I)
Descendant · 2 generations on · 8 of its ownK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
Descendant · 2 generations on · 3 of its ownK060418 8F Sherpa NX Guide CatheterMedtronic Vascular · 2006

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2002high 3 (2013) · low 0 (2007)2026

Class I recalls in this family

K132673 5F & 6F Launcher Guide Catheter, 5F Sherpa…cites it directly · 2013
K042489 6F Z4 Guide Cathetercites it directly · 2004
K083422 6F Taiga Guiding Catheter2 generations on · 2009

Most influential descendants

Showing 5 of 24 · See all

K0227647F Launcher Guide CatheterMedtronic Vascular · 2002 · cites it directly11descendants
K0307795F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003 · cites it directly10descendants
K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · cites it directly8descendants
K0234028F Launcher Guide CatheterMedtronic Vascular · 2002 · 2 generations on8descendants
K0604188F Sherpa NX Guide CatheterMedtronic Vascular · 2006 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981198	Medtronic Zuma Guiding Catheter	Medtronics Interventional Vascular	1998	25
0 (this device)	K021256	Z3 Guide Catheter	Medtronic Vascular	2002	—
+1	K022764	7F Launcher Guide Catheter	Medtronic Vascular	2002	13
+1	K030779	5F Medtronic Launcher Guide Catheter	Medtronic Vascular	2003	7
+1	K042489	6F Z4 Guide Catheter	Medtronic Vascular	2004	Class I
+2	K023402	8F Launcher Guide Catheter	Medtronic Vascular	2002	18
+2	K060418	8F Sherpa NX Guide Catheter	Medtronic Vascular	2006	—

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
2002	2	0
2003	2	0
2004	1	1
2005	1	0
2006	2	0
2009	1	1
2010	1	0
2011	1	0
2012	1	0
2013	3	1
2014	2	0
2016	1	0
2019	1	0
2021	1	0
2023	3	0
2025	1	0

FIG. 1 — Lineage of K021256, 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.

3 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? (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
*	K981198	Medtronic Zuma Guiding Catheter Summary page 1 …are substantially equivalent to the 6F Genius (K010579) with the exception of some component materials that are the same as materials used in the 6F Zuma Guide Catheter (K981198). The packaging materials are identical to the predicate devices. Biocompatibility tests performed per ISO10993 were chosen base…	Medtronics Interventional Vascular	1998	25
*	K010579	Stent Support Guide Catheter Summary page 1 …similar to the legally marketed predicate 6F Zuma™ and 6F Genius™ Guide Catheters. The manufacturing processes and design are substantially equivalent to the 6F Genius (K010579) with the exception of some component materials that are the same as materials used in the 6F Zuma Guide Catheter (K981198). The…	Medtronic Vascular	2001	27

Also cleared against K981198: 1 other device →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K022764	7F Launcher Guide Catheter	Medtronic Vascular	2002	11
K030779	5F Medtronic Launcher Guide Catheter	Medtronic Vascular	2003	10
K042489	6F Z4 Guide Catheter Class I	Medtronic Vascular	2004	8
K120585	Convey Guiding Catheter	Pendracare International, B.V.	2012	2
K141529	Alviguide Blue+ Interventional Cardiology Guiding Catheter	Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S	2014	0
K132556	Sheathless Eaucath Coronary Guide Catheter	Asahi Intecc Co., Ltd.	2013	0
K132673	5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding… Class I	Medtronic, Inc.	2013	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 15, 2021	Class II	Z-1248-2021	Process control	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Class II	Z-1246-2021	Process control	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Class II	Z-1245-2021	Process control	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Class II	Z-1247-2021	Process control	Sterility may be compromised due to an unsealed pouch
Oct 13, 2014	Class II	Z-0205-2015	Process control	Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of…
Jun 12, 2013	Class II	Z-1564-2013	Labeling mix-ups	Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.
Apr 5, 2006	Not classified	Z-0950-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0957-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0965-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1002-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0951-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0966-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1019-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1007-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0947-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0963-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0948-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0998-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0959-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1005-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0942-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0940-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0952-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0941-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0956-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0943-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0954-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0962-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1004-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0946-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1008-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0945-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0961-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0953-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0964-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0939-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0997-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0958-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1001-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0949-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1003-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0960-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-1006-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0937-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0968-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0955-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0996-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0999-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0938-06	Other	Potential for non-sterility due to loss of package integrity
Apr 5, 2006	Not classified	Z-0944-06	Other	Potential for non-sterility due to loss of package integrity

The 5 latest of 50 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 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 1191 Class I recalls
K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 1191 Class I recalls
K0834226F Taiga Guiding CatheterMedtronic Vascular · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K022764 (Medtronic Vascular, 2002) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K981198.

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® Z3 Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Z3 catheter is intended to be used in the coronary or peripheral vascular system.

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/K021256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021256: Z3 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/K021256

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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