510(k) · Cleared
Recalled · 2006Medtronic Zuma Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronics Interventional Vascular · DQY Catheter, Percutaneous
Cleared on Aug 7, 1998 after a 127-day review. The FDA summary names its predicate without a number. 3 of the 30 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it. It has been recalled 25 times.
- Decided
- Aug 7, 1998
- Review
- 127 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 25
- Predicates
- 0
29 later devices descend from it, 2 citing it directly. 3 of the 30 devices in this family, counting this one, have a Class I recall.
- This deviceK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998
- Descendant · cites it directly · 24 of its ownK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- Descendant · 2 generations on · 11 of its ownK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- Descendant · 2 generations on · 10 of its ownK030779 5F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003 · Recalled
- Descendant · 2 generations on · 8 of its ownK042489 6F Z4 Guide CatheterMedtronic Vascular · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K021256Z3 Guide CatheterMedtronic Vascular · 2002 · cites it directly24descendants
- K0227647F Launcher Guide CatheterMedtronic Vascular · 2002 · 2 generations on11descendants
- K0307795F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003 · 2 generations on10descendants
- K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · 2 generations on8descendants
- K0234028F Launcher Guide CatheterMedtronic Vascular · 2002 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | — |
| +1 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| +2 | K022764 | 7F Launcher Guide Catheter | Medtronic Vascular | 2002 | 13 |
| +2 | K030779 | 5F Medtronic Launcher Guide Catheter | Medtronic Vascular | 2003 | 7 |
| +2 | K042489 | 6F Z4 Guide Catheter | Medtronic Vascular | 2004 | Class I |
| +3 | K023402 | 8F Launcher Guide Catheter | Medtronic Vascular | 2002 | 18 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 1 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 1 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 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.
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
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 |
|---|---|---|---|
| * | — | Medtronic® Vector™ X Guiding Catheter Named without a submission number | |
| * | — | Cordis® Brite Tip® Guiding Catheter Named without a submission number |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2006 | Not classified | Z-1010-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1012-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1013-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1059-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1061-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1062-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1063-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1064-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1065-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1066-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1072-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1011-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1058-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1071-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1060-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1067-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1069-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1068-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1070-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1074-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1073-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1076-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1075-06 | Other | Potential for non-sterility due to loss of package integrity |
| Mar 17, 2003 | Not classified | Z-0799-03 | Other | The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label. |
| Mar 17, 2003 | Not classified | Z-0800-03 | Other | The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label. |
The 5 latest of 25 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
- K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 1191 Class I recalls
- K0834226F Taiga Guiding CatheterMedtronic Vascular · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021256 (Medtronic Vascular, 2002) has gone furthest, with 24 descendants of its own.
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® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma 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/K981198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981198: Medtronic Zuma Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981198
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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