510(k) · Cleared
ClearedSteerant™ Super Stiff Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQX Wire, Guide, Catheter
Cleared on Oct 24, 2023 as substantially equivalent to K101339 (Medtronic, Inc., 2010) after a 61-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Oct 24, 2023
- Review
- 61 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011906 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011906 Back-UP Meier GuidewireBoston Scientific Corp · 2001 · Recalled
- 2 generations backK020283 Back-UP Meier Steerable GuidewireBoston Scientific Corp · 2002 · Recalled
- 1 generation backK101339 Archer Super Stiff GuidewiresMedtronic, Inc. · 2010 · Recalled
- This deviceK232570 Steerant™ Super Stiff GuidewireMedtronic Vascular · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011906 | Back-UP Meier Guidewire | Boston Scientific Corp | 2001 | 1 |
| −2 | K020283 | Back-UP Meier Steerable Guidewire | Boston Scientific Corp | 2002 | 1 |
| −1 | K101339 | Archer Super Stiff Guidewires | Medtronic, Inc. | 2010 | 2 |
| 0 (this device) | K232570 | Steerant™ Super Stiff Guidewire | Medtronic Vascular | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K101339 | Archer Super Stiff GuidewiresSummary page 4…21 CFR 870.1330 Classification Product Code: DQX Classification Panel: Cardiovascular Predicate Device: Archer Super Stiff Guidewire (K101339) Reference Device: Cook Lunderquist Extra Stiff Wire Guide (K220137)… | 2010 |
| † | K220137 | Lunderquist Extra Stiff Wire Guide | 2022 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K101339.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 Medtronic Steerant Super Stiff Guidewire is intended to be used to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232570: Steerant™ Super Stiff Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232570
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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