510(k) · Cleared
ClearedLunderquist Wire Guide; DC 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 Jan 19, 2007 after a 219-day review. The FDA summary names no predicate by number. 19 later devices descend from it.
- Decided
- Jan 19, 2007
- Review
- 219 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK061670 Lunderquist Wire Guide; DC Wire GuideWilliam Cook Europe Aps · 2007
- Descendant · cites it directly · 13 of its ownK101339 Archer Super Stiff GuidewiresMedtronic, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 11 of its ownK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- Descendant · 3 generations on · 9 of its ownK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
- Descendant · 4 generations on · 8 of its ownK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
- Descendant · 5 generations on · 6 of its ownK192454 Wattson Temporary Pacing GuidewireVascular Solutions · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K101339Archer Super Stiff GuidewiresMedtronic, Inc. · 2010 · cites it directly13descendants
- K132623Medtronic Confida Brecker Curve GuidewireMedtronic · 2013 · 2 generations on11descendants
- K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015 · 3 generations on9descendants
- K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018 · 4 generations on8descendants
- K192454Wattson Temporary Pacing GuidewireVascular Solutions · 2020 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061670 | Lunderquist Wire Guide; DC Wire Guide | William Cook Europe Aps | 2007 | — |
| +1 | K101339 | Archer Super Stiff Guidewires | Medtronic, Inc. | 2010 | 2 |
| +2 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| +3 | K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2015 | — |
| +4 | K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2018 | — |
| +5 | K192454 | Wattson Temporary Pacing Guidewire | Vascular Solutions | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (19)
See all 193 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, K101339 (Medtronic, Inc., 2010) has gone furthest, with 13 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. 2007, 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 Lunderquist Wire Guide and the Lunderquist DC Wire Guide are intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061670: Lunderquist Wire Guide; DC Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061670
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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