510(k) · Cleared
ClearedAcs HI-Torque Iron Man Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cardiovascular Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Jan 22, 1997 as substantially equivalent to K942066 (Advanced Cardiovascular Systems, Inc., 1994) and 2 other predicates after a 128-day review. Its family tree reaches back 1 generation to 1994. 3 of the 40 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Jan 22, 1997
- Review
- 128 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K935997 (1994). 3 ancestors in all. 36 later devices descend from it, 2 citing it directly. 3 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK935997 Platinum Plus GuidewireBoston Scientific Corp · 1994 · Recalled
- This deviceK963702 Acs HI-Torque Iron Man Guide WireAdvanced Cardiovascular Systems, Inc. · 1997
- Descendant · cites it directly · 34 of its ownK982876 HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281…Guidant Corp. · 1998
- Descendant · 2 generations on · 32 of its ownK061984 TreasureAsahi Intecc Co., Ltd. · 2006
- Descendant · 2 generations on · 27 of its ownK071721 Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007
- Descendant · 3 generations on · 21 of its ownK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
- Descendant · 3 generations on · 17 of its ownK083146 Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 &…Asahi Intecc Co., Ltd. · 2008
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 36 · See all- K982876HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282Guidant Corp. · 1998 · cites it directly34descendants
- K061984TreasureAsahi Intecc Co., Ltd. · 2006 · 2 generations on32descendants
- K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007 · 2 generations on27descendants
- K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010 · 3 generations on21descendants
- K083146Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Asahi Intecc Co., Ltd. · 2008 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935997 | Platinum Plus Guidewire | Boston Scientific Corp | 1994 | 6 |
| 0 (this device) | K963702 | Acs HI-Torque Iron Man Guide Wire | Advanced Cardiovascular Systems, Inc. | 1997 | — |
| +1 | K982876 | HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282 | Guidant Corp. | 1998 | — |
| +2 | K061984 | Treasure | Asahi Intecc Co., Ltd. | 2006 | — |
| +2 | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | Asahi Intecc Co., Ltd. | 2007 | — |
| +3 | K103057 | Asahi Astato XS 20 Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2010 | — |
| +3 | K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 | Asahi Intecc Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 1 |
| 2020 | 1 | 0 |
| 2021 | 3 | 1 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 1 |
| 2026 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K942066 | Acs HI-Torque Extra S'port Guide WireSummary page 2…8 AS Summary of Substantial Equivalence: A comparison of the ACS HI-TORQUE IRON MAN™ Guide Wire to the predicate ACS Hi-Torque Extra S’Port™ Guide Wire (K942066, July 18, 1994 and K950156, April 5, 1995), indicates that the new guide wire is substantially equivalent to the predicate guide… | 1994 |
| * | K950156 | Acs HI-Torque Extra S'port (TM) Guide WireSummary page 2…y of Substantial Equivalence: A comparison of the ACS HI-TORQUE IRON MAN™ Guide Wire to the predicate ACS Hi-Torque Extra S’Port™ Guide Wire (K942066, July 18, 1994 and K950156, April 5, 1995), indicates that the new guide wire is substantially equivalent to the predicate guide wire with regard to the int… | 1995 |
| * | K935997 | Platinum Plus GuidewireSummary page 3…t of the ACS Hi-Torque Extra S’Port™ Guide Wire (K942066, July 18, 1994 and K950156, April 5, 1995) and the Boston Scientific Corporation .014” Platinum Plus Guide Wire (K935997, June 17, 1994), when used in combination with the JJIS Stent Delivery System, ACS TX 2000 Balloon Dilatation Catheter and the DV… | 1994 |
What descends from it? (36)
See all 362 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 IRON MAN™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.
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/K963702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963702: Acs HI-Torque Iron Man 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/K963702
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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