510(k) · Cleared
Recalled · Class II · 2022Double Flexible Tip Wire Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DQX Wire, Guide, Catheter
Cleared on Mar 19, 2018 as substantially equivalent to K150802 (Cook Incorporated, 2015) after a 266-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 19, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K770977 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
- 1 generation backK150802 Heavy Double Flexible Tipped Wire GuideCook Incorporated · 2015
- This deviceK171912 Double Flexible Tip Wire GuidesCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK181351 Double Flexible Tipped Wire GuidesCook Incorporated · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K181351Double Flexible Tipped Wire GuidesCook Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770977 | Cardiovascular Spring Guides | Lake Region Mfg., Inc. | 1977 | 1 |
| −1 | K150802 | Heavy Double Flexible Tipped Wire Guide | Cook Incorporated | 2015 | — |
| 0 (this device) | K171912 | Double Flexible Tip Wire Guides | Cook Incorporated | 2018 | — |
| +1 | K181351 | Double Flexible Tipped Wire Guides | Cook Incorporated | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K150802 | Heavy Double Flexible Tipped Wire GuideSummary page 4…ate Device: The predicate device manufactured by Cook Incorporated, the Heavy Double Flexible Tip Wire Guide, was cleared for commercial distribution under 510(k) number K150802, on May 28, 2015. Comparison to Predicate Device: It has been demonstrated that the Double Flexible Tipped Wire Guides are ident… | 2015 |
| † | K140485 | Mandrel Guidewire | 2014 |
| † | K142393 | Predicate Iii Guidewire | 2014 |
| † | K081337 | Approach Cto Wire Guide | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181351 | Double Flexible Tipped Wire Guides | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2022 | Class II | Z-1831-2022 | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. |
| Aug 16, 2022 | Class II | Z-1835-2022 | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 2 companies; a new generation was cleared every 38.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181351 (Cook Incorporated, 2018) has gone furthest, with 0 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. 2018, 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 Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171912: Double Flexible Tip Wire Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171912
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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