510(k) · Cleared
Recalled · 20068F Launcher Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Nov 6, 2002 as substantially equivalent to K022764 (Medtronic Vascular, 2002) after a 27-day review. Its family tree reaches back 3 generations to 1998. 1 of the 13 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 18 times.
- Decided
- Nov 6, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 18
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981198 (1998). 4 ancestors in all. 8 later devices descend from it, 6 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 2 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 1 generation backK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- This deviceK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002
- Descendant · cites it directly · 3 of its ownK060418 8F Sherpa NX Guide CatheterMedtronic Vascular · 2006
- Descendant · 2 generations on · 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 · cites it directly · 1 of its ownK091188 Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK141529 Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K132673 5F & 6F Launcher Guide Catheter, 5F Sherpa…2 generations on · 2013
Most influential descendants
Showing 5 of 8 · See all- K0604188F Sherpa NX Guide CatheterMedtronic Vascular · 2006 · cites it directly3descendants
- K0624205F Sherpa Active NX Guide CatheterMedtronic Vascular · 2006 · 2 generations on2descendants
- K103386Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide…Medtronic, Inc. · 2011 · cites it directly1descendant
- K091188Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd. · 2010 · cites it directly1descendant
- K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −2 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −1 | K022764 | 7F Launcher Guide Catheter | Medtronic Vascular | 2002 | 13 |
| 0 (this device) | K023402 | 8F Launcher Guide Catheter | Medtronic Vascular | 2002 | — |
| +1 | K060418 | 8F Sherpa NX Guide Catheter | Medtronic Vascular | 2006 | — |
| +2 | 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 |
| +1 | K091188 | Asahi Zenyteex Guiding Catheter | Asahi Intecc Co., Ltd. | 2010 | — |
| +1 | K141529 | Alviguide Blue+ Interventional Cardiology Guiding Catheter | Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S | 2014 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K022764 | 7F Launcher Guide Catheter | 2002 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060418 | 8F Sherpa NX Guide Catheter | 2006 | 3 |
| K103386 | Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide… | 2011 | 1 |
| K091188 | Asahi Zenyteex Guiding Catheter | 2010 | 1 |
| K141529 | Alviguide Blue+ Interventional Cardiology Guiding Catheter | 2014 | 0 |
| K132556 | Sheathless Eaucath Coronary Guide Catheter | 2013 | 0 |
| K030671 | Medtronioc 7F Launcher Biopsy Guide Catheter, Model LA7RVBB, Medtronic 8F Launcher… | 2003 | 0 |
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-0981-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0982-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0983-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0984-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0986-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0987-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0992-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0993-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0994-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0985-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0988-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0989-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0990-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0991-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-0995-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1042-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1041-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1043-06 | Other | Potential for non-sterility due to loss of package integrity |
The 5 latest of 18 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 4 years and passes through 2 companies; a new generation was cleared every 3 months on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K060418 (Medtronic Vascular, 2006) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K022764.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 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/K023402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023402: 8F 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/K023402
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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