510(k) · Cleared
ClearedZigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vadiswire Corporation · DQX Wire, Guide, Catheter
Cleared on Dec 18, 2014 as substantially equivalent to K053251 (Techdevice Corporation, 2006) and 1 other predicate after a 220-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 18, 2014
- Review
- 220 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933334 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933334 | Magic Torque Guidewire | Boston Scientific Corp | 1994 | 1 |
| −1 | K053251 | Techdevice Guidewire | Techdevice Corporation | 2006 | — |
| 0 (this device) | K141218 | Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System | Vadiswire Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K053251 | Techdevice GuidewireSummary page 5…ture. The individual guidewires used in the ZigiWire Systems consist of exchange length peripheral guidewires cleared under AdvanceCath (TechDevice) Corporation’s 510(k) K053251. TechDevice Corporation manufactures the guidewires used in the ZigiWire Systems for Vadiswire, which are individually the same a… | 2006 |
| * | K942382 | MS Amplatz Extra Stiff Guide WireSummary page 5…Predicate 510(k) AdvanceCath (TechDevice) Guidewire K053251 Amplatz Super Stiff Guidewire K942382 Testing Summary: To demonstrate substantial equivalence of the subject ZigiWire Guidewire Systems to the predicate devices, the… | 1994 |
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 20 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K053251.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ZigiWire Guidewire Systems facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. The ZigiWire Guidewire Systems are not intended for use in the coronary arteries or neurovasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141218: Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141218
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