510(k) · Cleared
ClearedAcs Wholey HI-Torque 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 May 30, 1986 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 30, 1986
- Review
- 23 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK861765 Acs Wholey HI-Torque Guide WireAdvanced Cardiovascular Systems, Inc. · 1986
- Descendant · cites it directly · 1 of its ownK120863 Wholey Guide Wire SystemCovidien, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK193571 Go2Wire Guide WireMerit Medical System, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK974560 Cordis Vanguard Steerable GuidewiresCordis Corp. · 1998
- Descendant · cites it directly · 0 of its ownK980119 Acs HI-Torque Wholey Supra Core Guide WireGuidant Corp. · 1998
- Descendant · cites it directly · 0 of its ownK961107 B. Braun GuidewiresB.Braun Medical, Inc. · 1996
Most influential descendants
Showing 5 of 5 · See all- K120863Wholey Guide Wire SystemCovidien, LLC · 2012 · cites it directly1descendant
- K193571Go2Wire Guide WireMerit Medical System, Inc. · 2020 · 2 generations on0descendants
- K974560Cordis Vanguard Steerable GuidewiresCordis Corp. · 1998 · cites it directly0descendants
- K980119Acs HI-Torque Wholey Supra Core Guide WireGuidant Corp. · 1998 · cites it directly0descendants
- K961107B. Braun GuidewiresB.Braun Medical, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861765 | Acs Wholey HI-Torque Guide Wire | Advanced Cardiovascular Systems, Inc. | 1986 | — |
| +1 | K120863 | Wholey Guide Wire System | Covidien, LLC | 2012 | — |
| +2 | K193571 | Go2Wire Guide Wire | Merit Medical System, Inc. | 2020 | — |
| +1 | K974560 | Cordis Vanguard Steerable Guidewires | Cordis Corp. | 1998 | — |
| +1 | K980119 | Acs HI-Torque Wholey Supra Core Guide Wire | Guidant Corp. | 1998 | — |
| +1 | K961107 | B. Braun Guidewires | B.Braun Medical, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
4 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?
- Of its descendants, K120863 (Covidien, LLC, 2012) has gone furthest, with 1 descendant 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) | — |
https://510kreport.com/device/K861765 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861765: Acs Wholey HI-Torque 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/K861765
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026