510(k) · Cleared
ClearedHI-Torque Versaturn Guide Wire
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 Aug 7, 2014 as substantially equivalent to K103101 (Abbott Vascular-Cardiac Therapies, 2011) after a 36-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- Aug 7, 2014
- Review
- 36 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913353 (1991). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 5 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 4 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 3 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- 2 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
- 1 generation backK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
- This deviceK141782 HI-Torque Versaturn Guide WireAbbott Vascular · 2014
- Descendant · cites it directly · 0 of its ownK173795 HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular · 2018
Most influential descendants
Showing 1 of 1 · See all- K173795HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −5 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −4 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −3 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| −2 | K072460 | HI-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular, Inc. | 2008 | — |
| −1 | K103101 | HI-Torque Balance Middleweight Elite | Abbott Vascular-Cardiac Therapies | 2011 | — |
| 0 (this device) | K141782 | HI-Torque Versaturn Guide Wire | Abbott Vascular | 2014 | — |
| +1 | 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 |
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 |
|---|---|---|---|
| * | K103101 | HI-Torque Balance Middleweight EliteSummary page 4…sification Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE MIDDLEWEIGHT ELITE (K103101, cleared February 10, 2011) 11. Device Description The HI-TORQUE VersaTurn Guide Wire Family includes steerable guide wires off… | 2011 |
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 |
|---|---|---|---|
| K173795 | HI-TORQUE TurnTrac Guide Wire Family | 2018 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K173795 (Abbott Vascular, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103101.
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 HI-TORQUE VersaTurn 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/K141782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141782: HI-Torque Versaturn Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141782
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