510(k) · Cleared
Recalled · 2006Medtronic 7F and 8F 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 Sep 4, 1998 after an 18-day review. The FDA summary names its predicate without a number. It has been recalled 10 times.
- Decided
- Sep 4, 1998
- Review
- 18 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 10
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Planning a device in DQY? 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? (3)
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® 6F Zuma™ Guiding Catheter Named without a submission number | |
| * | — | Medtronic® Vector™ Guiding Catheter Named without a submission number | |
| * | — | Cordis® Brite Tip® Guiding Catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2006 | Not classified | Z-1047-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1050-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1053-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1052-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1044-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1051-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1045-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1046-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1048-06 | Other | Potential for non-sterility due to loss of package integrity |
| Apr 5, 2006 | Not classified | Z-1049-06 | Other | Potential for non-sterility due to loss of package integrity |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant 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.
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/K982883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982883: Medtronic 7F and 8F 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/K982883
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026