510(k) · Cleared
ClearedHI-Torque Whisper View Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DQX Wire, Guide, Catheter
Cleared on Jun 22, 2006 as substantially equivalent to K030019 (Guidant Corp., 2003) after a 28-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 22, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002206 (2000). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
- 3 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
- 2 generations backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
- 1 generation backK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
- This deviceK061453 HI-Torque Whisper View Guide WireGuidant Corp. · 2006
- Descendant · cites it directly · 1 of its ownK090554 Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp · 2009
- Descendant · cites it directly · 0 of its ownK110479 Acuity Whisper View Guide WiresBoston Scientific Corp · 2011
- Descendant · cites it directly · 0 of its ownK082935 Vision Wire Coronary GuidewireBiotronik, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002206 | HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque… | Guidant Corp. | 2000 | — |
| −3 | K013092 | HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating | Guidant Corp. | 2001 | — |
| −2 | K020340 | Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat… | Guidant Corp. | 2002 | — |
| −1 | K030019 | Modification to HI-Torque Whisper Guidewire | Guidant Corp. | 2003 | — |
| 0 (this device) | K061453 | HI-Torque Whisper View Guide Wire | Guidant Corp. | 2006 | — |
| +1 | K090554 | Acuity Mailman and Strait-Trak Guidewire | Boston Scientific Corp | 2009 | — |
| +1 | K110479 | Acuity Whisper View Guide Wires | Boston Scientific Corp | 2011 | — |
| +1 | K082935 | Vision Wire Coronary Guidewire | Biotronik, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K030019 | Modification to HI-Torque Whisper GuidewireSummary page 1…ame; Guide Wire Classification Name: Catheter Guide Wire, (21 CFR 870.1330, Product Code DQX) Predicate 1I-TORQUE WHISPERTM Guide Wire, K030019 Device Description The guide wire is comprised of a stainless steel tapered core with a flexible tip, jacketed by tungsten-lo… | 2003 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K090554 (Boston Scientific Corp, 2009) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K030019.
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?
The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061453 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061453: HI-Torque Whisper View Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061453
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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