510(k) · Cleared
Recalled · Class I · 2013GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQX Wire, Guide, Catheter
Cleared on Dec 4, 2009 as substantially equivalent to K001969 (Medtronic Vascular, 2000) and 1 other predicate after a 185-day review. Its family tree reaches back 1 generation to 1997. 3 of the 13 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Dec 4, 2009
- Review
- 185 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970466 (1997). 2 ancestors in all. 10 later devices descend from it, 3 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK970466 Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · Recalled (Class I)
- This deviceK091582 GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009
- Descendant · cites it directly · 7 of its ownK112957 HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
- Descendant · 2 generations on · 6 of its ownK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK240997 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2024
- Descendant · 3 generations on · 1 of its ownK152404 Hi-Torque Command 18 Guide WireAbbott Vascular · 2015
- Descendant · cites it directly · 1 of its ownK100470 GTX 12 GidewireMedtronic, Inc. · 2010 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011 · cites it directly7descendants
- K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · 2 generations on6descendants
- K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical · 2024 · 3 generations on1descendant
- K152404Hi-Torque Command 18 Guide WireAbbott Vascular · 2015 · 3 generations on1descendant
- K100470GTX 12 GidewireMedtronic, Inc. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970466 | Radius Ptca Guidewire | Radius Medical Technologies, Inc. | 1997 | Class I |
| 0 (this device) | K091582 | GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15 | Medtronic Vascular | 2009 | — |
| +1 | K112957 | HI-Torque Powerturn | Abbott Vascular-Cardiac Therapies | 2011 | — |
| +2 | K122573 | HI-Torque Command Guide Wire Family | Abbott Vascular, Inc. | 2012 | — |
| +3 | K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | Abbott Medical | 2024 | — |
| +3 | K152404 | Hi-Torque Command 18 Guide Wire | Abbott Vascular | 2015 | — |
| +1 | K100470 | GTX 12 Gidewire | Medtronic, Inc. | 2010 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K001969 | GT2 Fusion Guide Wire, Model NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 | 2000 |
| * | K970466 | Radius Ptca GuidewireSummary page 1…PTCA Guidewire Classification Wire, Guide, Cardiovascular Name: Predicate Devices: GT2 Fusion Guidewire (KOO 1969) Radius PTCA Guidewire (K970466) Device The Medtronic GTX Guidewire are steerable guide wires Description: available in a variety of stiff… | 1997 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2013 | Class I | Z-0264-2014 | Nonconforming Material/Component | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K112957 (Abbott Vascular-Cardiac Therapies, 2011) has gone furthest, with 7 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. 2009, 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?
Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091582: GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091582
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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