510(k) · Cleared
ClearedAcs HI-Torque Wiggle Guide Wire with Microglide 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 Mar 8, 1999 as substantially equivalent to K913353 (Advanced Cardiovascular Systems, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Mar 8, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883000 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK883000 Acs Angioscope Guide WireAdvanced Cardiovascular Systems, Inc. · 1988
- This deviceK984394 Acs HI-Torque Wiggle Guide Wire with Microglide CoatingGuidant Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883000 | Acs Angioscope Guide Wire | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| 0 (this device) | K984394 | Acs HI-Torque Wiggle Guide Wire with Microglide Coating | Guidant Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K913353 | Vascular Guide WireSummary page 1…Name: Guide Wire Device Classification Name: Catheter Guide Wire (74DQX) Predicate Device: ACS HI-TORQUE FLOPPY II® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating (K913353) ACS Angioscope Guide Wire (K883000) Device Description: The ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is a gui… | 1991 |
| * | K883000 | Acs Angioscope Guide WireSummary page 1…ion Name: Catheter Guide Wire (74DQX) Predicate Device: ACS HI-TORQUE FLOPPY II® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating (K913353) ACS Angioscope Guide Wire (K883000) Device Description: The ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is a guide wire with a nominal diameter of 0.… | 1988 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K913353.
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 intended use of the ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or 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/K984394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984394: Acs HI-Torque Wiggle Guide Wire with Microglide Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984394
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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