510(k) · Cleared
ClearedCordis Stabilizer Plus XS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · DQX Wire, Guide, Catheter
Cleared on Oct 25, 1996 as substantially equivalent to K953760 (Cordis Corp., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 25, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935997 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935997 Platinum Plus GuidewireBoston Scientific Corp · 1994 · Recalled
- This deviceK962932 Cordis Stabilizer Plus XSCordis Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935997 | Platinum Plus Guidewire | Boston Scientific Corp | 1994 | 6 |
| 0 (this device) | K962932 | Cordis Stabilizer Plus XS | Cordis Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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.
Planning a device in DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K953760 | Cordis Wizdom Steerable GuidewireSummary page 1…Common or Usual Name: Catheter Guide Wire Proprietary Name: Cordis STABILIZER Plus XS Steerable Guidewire Name of Predicate Devices Cordis WIZDOM Steerable Guidewire (K953760) Meditech/Boston Scientific Platinum Plus™ Guidewire (K935997) Scimed/Boston Scientific Platinum Plus™ Coronary Guidewire Classi… | 1995 |
| * | K935997 | Platinum Plus GuidewireSummary page 1…ordis STABILIZER Plus XS Steerable Guidewire Name of Predicate Devices Cordis WIZDOM Steerable Guidewire (K953760) Meditech/Boston Scientific Platinum Plus™ Guidewire (K935997) Scimed/Boston Scientific Platinum Plus™ Coronary Guidewire Classification Catheter Guide Wire, Class II - 21 CFR 870.1330 74DQ… | 1994 |
| * | — | Scimed/Boston Scientific Platinum Plus™ Coronary Guidewire 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K953760.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Cordis STABILIZER Plus XS Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
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/K962932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962932: Cordis Stabilizer Plus XS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962932
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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