510(k) · Cleared
Recalled · 2011Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire Accessory Kits
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 15, 1995 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it. It has been recalled once.
- Decided
- May 15, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 0
29 later devices descend from it, 1 citing it directly.
- This deviceK950752 Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire…Advanced Cardiovascular Systems, Inc. · 1995
- Descendant · cites it directly · 28 of its ownK032411 JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003
- Descendant · 2 generations on · 22 of its ownK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
- Descendant · 3 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
- Descendant · 4 generations on · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
- Descendant · 5 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K032411JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003 · cites it directly28descendants
- K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006 · 2 generations on22descendants
- K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 3 generations on21descendants
- K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · 4 generations on18descendants
- K111338Wildcat CatheterAvinger, Inc. · 2011 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950752 | Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire Accessory Kits | Advanced Cardiovascular Systems, Inc. | 1995 | — |
| +1 | K032411 | JS Vascular Guide Wire Vise/Torque Device | Js Vascular, Inc. | 2003 | — |
| +2 | K060745 | Asahi Tornus Support Catheter with Torque Device Accessory | Asahi Intecc Co., Ltd. | 2006 | — |
| +3 | K083313 | Wildcat 7F Guidewire Support Catheter | Avinger, Inc. | 2009 | — |
| +4 | K102022 | Wildcat 6F Guidewire Support Catheter Model W400L and W400S | Avinger, Inc. | 2010 | — |
| +5 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032411 | JS Vascular Guide Wire Vise/Torque Device | 2003 | 28 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2011 | Not classified | Z-2791-2011 | Process control | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032411 (Js Vascular, Inc., 2003) has gone furthest, with 28 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) | — |
https://510kreport.com/device/K950752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950752: Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire Accessory Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950752
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026