510(k) · Cleared
ClearedLunderquist Extra Stiff Wire Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
William Cook Europe Aps · DQX Wire, Guide, Catheter
Cleared on Dec 7, 2017 as substantially equivalent to K061670 (William Cook Europe Aps, 2007) after a 197-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.
- Decided
- Dec 7, 2017
- Review
- 197 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061670 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK061670 Lunderquist Wire Guide; DC Wire GuideWilliam Cook Europe Aps · 2007
- This deviceK171513 Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2017
- Descendant · cites it directly · 2 of its ownK220137 Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2022
- Descendant · 2 generations on · 0 of its ownK251596 Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2025
- Descendant · 2 generations on · 0 of its ownK230418 Mighty Wire Guide WireMerit Medical Systems, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061670 | Lunderquist Wire Guide; DC Wire Guide | William Cook Europe Aps | 2007 | — |
| 0 (this device) | K171513 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2017 | — |
| +1 | K220137 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2022 | — |
| +2 | K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2025 | — |
| +2 | K230418 | Mighty Wire Guide Wire | Merit Medical Systems, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 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.
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 |
|---|---|---|---|
| * | K061670 | Lunderquist Wire Guide; DC Wire GuideSummary page 4…870.1330 DQX Class II, Cardiovascular Predicate Devices: The Lunderquist Extra Stiff Wire Guide and Lunderquist Extra Stiff DC Wire Guide (William Cook Europe ApS, K061670) were cleared for market on January 19, 2007. The predicate devices are PTFE-coated stainless steel wire guides with an outer dia… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220137 | Lunderquist Extra Stiff Wire Guide | 2022 | 2 |
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?
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171513: Lunderquist Extra Stiff Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171513
Report an extraction error
Are you the manufacturer?
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