510(k) · Cleared
ClearedAcs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic Coating
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 Apr 24, 1998 as substantially equivalent to K963702 (Advanced Cardiovascular Systems, Inc., 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Apr 24, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913353 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 2 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 1 generation backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- This deviceK980294 Acs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −2 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −1 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| 0 (this device) | K980294 | Acs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic Coating | Guidant Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K963702 | Acs HI-Torque Iron Man Guide WireSummary page 1…Coating ACS HI-TORQUE® Device Common Name: Guide Wire Device Classification Name: Catheter Guide Wire (74DQX) 3. Predicate Device: ACS HI-TORQUE® IRON MAN™ Guide Wire (K963702) ACS HI-TORQUE®*BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K973494) 4. Device Description: The ACS HI-TORQUE® SU… | 1997 |
| * | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance…Summary page 1…: Catheter Guide Wire (74DQX) 3. Predicate Device: ACS HI-TORQUE® IRON MAN™ Guide Wire (K963702) ACS HI-TORQUE®*BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K973494) 4. Device Description: The ACS HI-TORQUE® SUPER S’PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wi… | 1997 |
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 7 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K963702.
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 ACS HI-TORQUE?® SUPER S’PORT™ Guide Wire with Hydrocoatm Hydrophilic Coating is steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE?® SUPER S’PORT™ Guide Wire with Hydrocoat Hydrophilic Coating is also intended to facilitate the placement of equipment, such as atherectomy and stent devices, during other diagnostic and therapeutic intravascular 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/K980294 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980294: Acs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980294
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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