510(k) · Cleared
Recalled · Class I · 20195F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 22, 2013 as substantially equivalent to K103386 (Medtronic, Inc., 2011) and 3 other predicates after a 56-day review. Its family tree reaches back 6 generations to 1998. 2 of the 11 devices in its family, counting itself, have a Class I recall. It has been recalled 191 times, including 191 Class I recalls.
- Decided
- Oct 22, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 191 (191 Class I)
- Predicates
- 4
Its longest line of descent runs back 6 generations to K981198 (1998). 10 ancestors in all. No later device cites it as a predicate yet. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 5 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 4 generations backK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- 3 generations backK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- 2 generations backK060418 8F Sherpa NX Guide CatheterMedtronic Vascular · 2006
- 1 generation backK062420 5F Sherpa Active NX Guide CatheterMedtronic Vascular · 2006
- This deviceK132673 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter…Medtronic, Inc. · 2013
Class I recalls in this family
- K042489 6F Z4 Guide Catheterdirect predicate · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −5 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −4 | K022764 | 7F Launcher Guide Catheter | Medtronic Vascular | 2002 | 13 |
| −3 | K023402 | 8F Launcher Guide Catheter | Medtronic Vascular | 2002 | 18 |
| −2 | K060418 | 8F Sherpa NX Guide Catheter | Medtronic Vascular | 2006 | — |
| −1 | K062420 | 5F Sherpa Active NX Guide Catheter | Medtronic Vascular | 2006 | — |
| 0 (this device) | K132673 | 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4… | Medtronic, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
| 2011 | 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.
2 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K103386 | Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide…Summary page 2…Device 510(W Clearance Date 5F Launcher& K(103386 02/11/2011 GuideCatheter _______ 6F Launcher® K(021256… | 2011 |
| * | K021256 | Z3 Guide CatheterSummary page 2…5F Launcher& K(103386 02/11/2011 GuideCatheter _______ 6F Launcher® K(021256 05/17/2002 GuideCatheter _______ 5F Sherpa® Guide K(062420… | 2002 |
| * | K062420 | 5F Sherpa Active NX Guide CatheterSummary page 2…6F Launcher® K(021256 05/17/2002 GuideCatheter _______ 5F Sherpa® Guide K(062420 09/08/2006 Catheter 6F Sherpa® (Z4) K(042489 12/13/2004J… | 2006 |
| * | K042489 | 6F Z4 Guide CatheterSummary page 2…______ 5F Sherpa® Guide K(062420 09/08/2006 Catheter 6F Sherpa® (Z4) K(042489 12/13/2004J GuidingCatheter ______________ Device The Medtronic Launcher G… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2019 | Class I | Z-2657-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2632-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2748-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2587-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2594-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2665-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2661-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2576-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2742-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2679-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2716-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2655-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2642-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2569-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2714-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2577-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2584-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2704-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2629-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2751-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2603-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2703-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2595-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2690-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2695-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2667-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2578-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2746-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2648-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2621-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2701-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2693-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2645-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2698-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2743-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2708-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2729-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2562-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2623-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2620-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2619-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2653-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2669-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2618-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2624-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2641-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2640-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2702-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2734-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
| Mar 15, 2019 | Class I | Z-2582-2019 | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. |
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.
- K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 1191 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 8 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 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 as stated in the FDA summary.
https://510kreport.com/device/K132673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132673: 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132673
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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