510(k) · Cleared
Recalled · 2007Silverstreak Hydrophilic Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · DQX Wire, Guide, Catheter
Cleared on Dec 11, 1998 after a 143-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 11, 1998
- Review
- 143 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK982543 Silverstreak Hydrophilic GuidewireMicro Therapeutics, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK124007 Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange…Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK193548 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
- Descendant · 3 generations on · 0 of its ownK201690 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
- Descendant · cites it directly · 0 of its ownK994141 Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire…Medtronic Ave, Inc. · 2000
Most influential descendants
Showing 4 of 4 · See all- K124007Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion…Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · 2013 · cites it directly2descendants
- K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · 2 generations on1descendant
- K201690Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · 3 generations on0descendants
- K994141Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter…Medtronic Ave, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982543 | Silverstreak Hydrophilic Guidewire | Micro Therapeutics, Inc. | 1998 | — |
| +1 | K124007 | Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire… | Micro Therapeutics, Inc. D/B/A: Ev3, Inc. | 2013 | — |
| +2 | K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
| +3 | K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
| +1 | K994141 | Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide… | Medtronic Ave, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 2 | 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-10 Guidewire Named without a submission number | |
| * | — | B. Braun Guidewire Introducer Named without a submission number | |
| * | — | Transend-10 Guidewire Named without a submission number | |
| * | — | B. Braun Guidewire Torque Device Named without a submission number |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2007 | Not classified | Z-0839-2007 | Other | Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K124007 (Micro Therapeutics, Inc. D/B/A: Ev3, Inc., 2013) has gone furthest, with 2 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 SilverSpeed guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/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/K982543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982543: Silverstreak Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982543
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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