510(k) · Cleared
ClearedHI-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Standard Guide Wire with Hydrocoat Hydrophilic
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 Mar 13, 1998 after an 81-day review. The FDA summary names its predicate without a number. 3 of the 106 devices in its family, counting itself, have a Class I recall. 105 later devices descend from it.
- Decided
- Mar 13, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
105 later devices descend from it, 4 citing it directly. 3 of the 106 devices in this family, counting this one, have a Class I recall.
- This deviceK974773 HI-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 1998
- Descendant · cites it directly · 104 of its ownK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- Descendant · 2 generations on · 92 of its ownK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- Descendant · 2 generations on · 79 of its ownK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- Descendant · 2 generations on · 60 of its ownK052339 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005
- Descendant · 2 generations on · 59 of its ownK052022 Asahi Ptca Guide Wire FielderAsahi Intecc Co., Ltd. · 2005
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 105 · See all- K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Jomed, Inc. · 2002 · cites it directly104descendants
- K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003 · 2 generations on92descendants
- K041531Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004 · 2 generations on79descendants
- K052339Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005 · 2 generations on60descendants
- K052022Asahi Ptca Guide Wire FielderAsahi Intecc Co., Ltd. · 2005 · 2 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974773 | HI-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque… | Guidant Corp. | 1998 | — |
| +1 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| +2 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| +2 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| +2 | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| +2 | K052022 | Asahi Ptca Guide Wire Fielder | Asahi Intecc Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 1 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 1 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 1 |
| 2026 | 2 | 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? (11)
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 |
|---|---|---|---|
| * | — | HI-TORQUE FLOPPY® Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | HI-TORQUE STANDARD® Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | HI-TORQUE INTERMEDIATE® Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | HI-TORQUE APPROACH® Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | HI-TORQUE FLOPPY II® Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | HI-TORQUE TRAVERSE® Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | ACS HI-TORQUE EXTRA S’PORT™ Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | HI-TORQUE FLOPPY® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | HI-TORQUE FLOPPY II® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | ACS HI-TORQUE IRON MAN® Guide Wire with MICROGLIDE® Coating Named without a submission number | |
| * | — | ChoICE™ PT Plus Guide Wire Named without a submission number |
What descends from it? (105)
See all 1054 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002… | 2002 | 104 |
| K063819 | Asahi Ptca Guide Wire, Fielder FC | 2007 | 51 |
| K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | 2006 | 49 |
| K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | 2007 | 27 |
Has anything in its family been recalled? (3 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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K022762 (Jomed, Inc., 2002) has gone furthest, with 104 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?
Facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE EXTRA S’PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE IRON MANT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974773: HI-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Standard Guide Wire with Hydrocoat Hydrophilic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974773
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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