510(k) · Cleared
Recalled · Class II · 2017Traxcess .007 Mini Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Sep 30, 2016 as substantially equivalent to K153053 (MicroVention, Inc., 2015) after a 92-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 30, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- MOF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953533 (1995). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 5 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 4 generations backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- 3 generations backK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
- 2 generations backK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
- 1 generation backK153053 Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015
- This deviceK161803 Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK201487 Traxcess 7 Mini GuidewireMicroVention, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK163154 Traxcess 7 Mini XSoft GuidewireMicroVention, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −5 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −4 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| −3 | K080863 | Traxcess 0.014 Hydrophilic Guidewire | MicroVention, Inc. | 2008 | — |
| −2 | K133725 | Traxcess 14 Guidewire | MicroVention, Inc. | 2014 | — |
| −1 | K153053 | Traxcess Pro 14 Guidewire | MicroVention, Inc. | 2015 | — |
| 0 (this device) | K161803 | Traxcess .007 Mini Guidewire | MicroVention, Inc. | 2016 | — |
| +1 | K201487 | Traxcess 7 Mini Guidewire | MicroVention, Inc. | 2020 | — |
| +1 | K163154 | Traxcess 7 Mini XSoft Guidewire | MicroVention, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 MOF? 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 MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K153053 | Traxcess Pro 14 GuidewireSummary page 4…gical and Physical Medicine Devices (Office of Device Evaluation, CDRH) PREDICATE DEVICE [807.92(a)(3)] Traxcess® 14 SELECT Guidewire (K153053) DEVICE DESCRIPTION [807.92(a)(4)] Traxcess .007" Mini Guidewire is a coiled wire that is designed to fit inside a percutaneou… | 2015 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Aug 7, 2017 | Class II | Z-3103-2017 | Under Investigation by firm | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K201487 (MicroVention, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153053.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
Traxcess .007" Mini Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not indicated for use in coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161803: Traxcess .007 Mini Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161803
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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