510(k) · Cleared
ClearedHI-TORQUE TurnTrac Guide Wire Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular · DQX Wire, Guide, Catheter
Cleared on Jan 12, 2018 as substantially equivalent to K141782 (Abbott Vascular, 2014) after a 29-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jan 12, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913353 (1991). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 6 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 5 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 4 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- 3 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
- 2 generations backK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
- 1 generation backK141782 HI-Torque Versaturn Guide WireAbbott Vascular · 2014
- This deviceK173795 HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −6 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −5 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −4 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| −3 | K072460 | HI-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular, Inc. | 2008 | — |
| −2 | K103101 | HI-Torque Balance Middleweight Elite | Abbott Vascular-Cardiac Therapies | 2011 | — |
| −1 | K141782 | HI-Torque Versaturn Guide Wire | Abbott Vascular | 2014 | — |
| 0 (this device) | K173795 | HI-TORQUE TurnTrac Guide Wire Family | Abbott Vascular | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K141782 | HI-Torque Versaturn Guide WireSummary page 4…Catheter Guide Wire (21 CFR 870.1330; Product Code - DQX) 10. Predicate Device Name HI-TORQUE VersaTurn Guide Wire Family (K141782, cleared on August 7, 2014) 11. Device Description The HI-TORQUE (HT) TurnTrac Guide Wire F… | 2014 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
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 HI-TORQUE® TurnTrac Guide Wire Family is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and /or reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173795: HI-TORQUE TurnTrac Guide Wire Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173795
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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