510(k) · Cleared
ClearedHI-Torque Advance and Advance Lite Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation · DQX Wire, Guide, Catheter
Cleared on May 30, 2006 after a 98-day review. The FDA summary names its predicate without a number. 1 of the 19 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it.
- Decided
- May 30, 2006
- Review
- 98 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- This deviceK060449 HI-Torque Advance and Advance Lite Guide WireGuidant Corporation · 2006
- Descendant · cites it directly · 9 of its ownK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 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 · 2 generations on · 4 of its ownK101011 HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK152709 HI-Torque BalanceAbbott Vascular · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K121398 Charlie Guidewire (Regular), Charlie Guidewire…3 generations on · 2012
Most influential descendants
Showing 5 of 18 · See all- K091825HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009 · cites it directly9descendants
- K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011 · cites it directly7descendants
- K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · 2 generations on6descendants
- K101011HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010 · 2 generations on4descendants
- K152709HI-Torque BalanceAbbott Vascular · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060449 | HI-Torque Advance and Advance Lite Guide Wire | Guidant Corporation | 2006 | — |
| +1 | K091825 | HI-Torque Progress Guide Wire Family | Abbott Vascular, Inc. | 2009 | — |
| +1 | K112957 | HI-Torque Powerturn | Abbott Vascular-Cardiac Therapies | 2011 | — |
| +2 | K122573 | HI-Torque Command Guide Wire Family | Abbott Vascular, Inc. | 2012 | — |
| +2 | K101011 | HI-Torque Balance Middleweight Universal | Abbott Vascular, Inc. | 2010 | — |
| +3 | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | — | ACS 0.014" Hi-Torque Floppy PATHFINDER Guide Wire Named without a submission number |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 112 Class I recalls
What does this lineage say?
- Of its descendants, K091825 (Abbott Vascular, Inc., 2009) has gone furthest, with 9 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.
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 interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060449: HI-Torque Advance and Advance Lite 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/K060449
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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