510(k) · Cleared
ClearedAgility Steerable Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · DQX Wire, Guide, Catheter
Cleared on Sep 23, 1999 after a 133-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 23, 1999
- Review
- 133 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK991646 Agility Steerable GuidewireCordis Neurovascular, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK100351 Neuroscout Steerable GuidewireCodman & Shurtleff, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK121776 Agility Steerable Guidewire Neuroscout Steerable GudiewireCodman & Shurtleff, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK151825 Viradius NeurowireMivi Neuroscience, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK133625 Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard &…Codman & Shurtleff, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK023700 PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 2002 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K100351Neuroscout Steerable GuidewireCodman & Shurtleff, Inc. · 2010 · cites it directly3descendants
- K121776Agility Steerable Guidewire Neuroscout Steerable GudiewireCodman & Shurtleff, Inc. · 2012 · cites it directly1descendant
- K151825Viradius NeurowireMivi Neuroscience, Inc. · 2015 · 2 generations on0descendants
- K133625Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM &…Codman & Shurtleff, Inc. · 2014 · 2 generations on0descendants
- K023700PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991646 | Agility Steerable Guidewire | Cordis Neurovascular, Inc. | 1999 | — |
| +1 | K100351 | Neuroscout Steerable Guidewire | Codman & Shurtleff, Inc. | 2010 | — |
| +1 | K121776 | Agility Steerable Guidewire Neuroscout Steerable Gudiewire | Codman & Shurtleff, Inc. | 2012 | — |
| +2 | K151825 | Viradius Neurowire | Mivi Neuroscience, Inc. | 2015 | — |
| +2 | K133625 | Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN… | Codman & Shurtleff, Inc. | 2014 | — |
| +1 | K023700 | PVS 1600 Synchro 0.010 Neuro Guide Wire | Precision Vascular Systems, Inc. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | — | Dasher® Named without a submission number | |
| * | — | TRANSEND™ Guidewire Named without a submission number | |
| * | — | INSTINCT™ Guidewire Named without a submission number | |
| * | — | ESSENCE™ Guidewire Named without a submission number |
What descends from it? (5)
3 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, K100351 (Codman & Shurtleff, Inc., 2010) has gone furthest, with 3 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) | — |
What is it indicated for?
The Cordis Endovascular AGILITY™ Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral 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/K991646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991646: Agility Steerable Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991646
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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