510(k) · Cleared
ClearedCordis Wizdom Steerable Guidewire
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 Nov 7, 1995 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 7, 1995
- Review
- 88 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK953760 Cordis Wizdom Steerable GuidewireCordis Corp. · 1995
- Descendant · cites it directly · 2 of its ownK040592 Cordis Steer-IT Deflecting Tip GuidewireCordis Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK070212 CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM…Ovalum, Ltd. · 2007
- Descendant · 3 generations on · 0 of its ownK171897 Approach CTO Microwire GuideCook Incorporated · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK990823 PVS 1400 GuidewirePrecision Vascular Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK963214 Cordis ST Steerable GuidewireCordis Corp. · 1996
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040592Cordis Steer-IT Deflecting Tip GuidewireCordis Corp. · 2004 · cites it directly2descendants
- K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd. · 2007 · 2 generations on1descendant
- K171897Approach CTO Microwire GuideCook Incorporated · 2017 · 3 generations on0descendants
- K990823PVS 1400 GuidewirePrecision Vascular Systems, Inc. · 1999 · cites it directly0descendants
- K963214Cordis ST Steerable GuidewireCordis Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953760 | Cordis Wizdom Steerable Guidewire | Cordis Corp. | 1995 | — |
| +1 | K040592 | Cordis Steer-IT Deflecting Tip Guidewire | Cordis Corp. | 2004 | — |
| +2 | K070212 | CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop… | Ovalum, Ltd. | 2007 | — |
| +3 | K171897 | Approach CTO Microwire Guide | Cook Incorporated | 2017 | 3 |
| +1 | K990823 | PVS 1400 Guidewire | Precision Vascular Systems, Inc. | 1999 | — |
| +1 | K963214 | Cordis ST Steerable Guidewire | Cordis Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040592 (Cordis Corp., 2004) has gone furthest, with 2 descendants of its own.
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) | — |
https://510kreport.com/device/K953760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953760: Cordis Wizdom Steerable Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953760
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026