510(k) · Cleared
Recalled · Class II · 2013Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 11, 2011 as substantially equivalent to K030779 (Medtronic Vascular, 2003) and 1 other predicate after an 85-day review. Its family tree reaches back 4 generations to 1998. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 11, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981198 (1998). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 3 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 2 generations backK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- 1 generation backK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- This deviceK103386 Medtronic Vascular - Hub Material Modification to the 5F and 8F…Medtronic, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK132673 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter…Medtronic, Inc. · 2013 · Recalled (Class I)
Class I recalls in this family
- K132673 5F & 6F Launcher Guide Catheter, 5F Sherpa…cites it directly · 2013
Most influential descendants
Showing 1 of 1 · See all- K1326735F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding…Medtronic, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −3 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −2 | K022764 | 7F Launcher Guide Catheter | Medtronic Vascular | 2002 | 13 |
| −1 | K023402 | 8F Launcher Guide Catheter | Medtronic Vascular | 2002 | 18 |
| 0 (this device) | K103386 | Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R)… | Medtronic, Inc. | 2011 | — |
| +1 | K132673 | 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4… | Medtronic, Inc. | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
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? (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 | Decided |
|---|---|---|---|
| * | K030779 | 5F Medtronic Launcher Guide CatheterSummary page 1…Medtronic Vascular SF Launcher® Guide Catheter Medtronic Vascular 8F Launcher® Guide Catheter Guiding Catheter Catheter, Percutaneous 21CFR 870.1250, Product Code DQY K030779 - SF Launcher® Guide Catheter. K023402 - 8F Launcher® Guide Catheter The Medtronic Launcher Guide Catheter is constructed with a… | 2003 |
| * | K023402 | 8F Launcher Guide CatheterSummary page 1…atheter Medtronic Vascular 8F Launcher® Guide Catheter Guiding Catheter Catheter, Percutaneous 21CFR 870.1250, Product Code DQY K030779 - SF Launcher® Guide Catheter. K023402 - 8F Launcher® Guide Catheter The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, o… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132673 | 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding… Class I | 2013 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
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
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 6 of the 6 ancestors have a recall of any class.
- Of its descendants, K132673 (Medtronic, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K030779.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
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/K103386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103386: Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103386
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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