510(k) · Cleared
Recalled · Class II · 2022Mandril Wire Guide
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 30, 2018 as substantially equivalent to K143135 (Neometrics, Inc., 2015) after a 270-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Mar 30, 2018
- Review
- 270 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 3
- 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 backK143135 Spring Coil GuidewireNeometrics, Inc. · 2015
- This deviceK171997 Mandril Wire GuideCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK181353 Lunderquist® Fixed Core Wire GuideCook Incorporated · 2019
Most influential descendants
Showing 1 of 1 · See all- K181353Lunderquist® Fixed Core Wire GuideCook Incorporated · 2019 · 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 | K143135 | Spring Coil Guidewire | Neometrics, Inc. | 2015 | — |
| 0 (this device) | K171997 | Mandril Wire Guide | Cook Incorporated | 2018 | — |
| +1 | K181353 | Lunderquist® Fixed Core Wire Guide | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K143135 | Spring Coil GuidewireSummary page 4…Regulation: 21 CFR §870.1330 Product Code: DQX Predicate Device: The predicate device is the Spring Coil Guidewire (Neometrics, Inc., K143135) cleared for market on February 20, 2015. Reference Device: The reference device is the ASAHI Peripheral Guide Wires (Asahi Inte… | 2015 |
| † | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | 2015 |
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 |
|---|---|---|---|
| K181353 | Lunderquist® Fixed Core Wire Guide | 2019 | 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-1843-2022 | 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-1829-2022 | 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-1830-2022 | 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 3 companies; a new generation was cleared every 37.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181353 (Cook Incorporated, 2019) 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?
To facilitate the placement of devices during diagnostic or interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171997 · printed Nov 3, 2026
Cite this page
510(k) Report. “K171997: Mandril Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K171997
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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