510(k) Report

510(k) · Cleared

Cleared

Traxcess 0.014 Hydrophilic Guidewire

K080863510(k) TraditionalCleared Apr 17, 200820-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

MicroVention, Inc. · DQX Wire, Guide, Catheter

Cleared on Apr 17, 2008 as substantially equivalent to K063695 (Terumo Medical Corp., 2007) and 2 other predicates after a 20-day review. Its family tree reaches back 3 generations to 1995. 12 later devices descend from it.

Decided
Apr 17, 2008
Review
20 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K953533 (1995). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor2014: 1 descendant cleared2009: 1 descendant cleared2019: 1 descendant cleared2020: 3 descendants cleared2015: 1 descendant cleared2026: 2 descendants cleared2018: 1 descendant cleared2016: 2 descendants clearedK953533 · Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil · Terumo Medical Corp. · 1995K961445 · Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil · Terumo Medical Corp. · 1996K063695 · Runthrough NS · Terumo Medical Corp. · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K063695 · Runthrough NS · Terumo Medical Corp. · 2007 · recalledK961445 · Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil · Terumo Medical Corp. · 1996K953533 · Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil · Terumo Medical Corp. · 19950
  1. Root · 3 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
  2. 2 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
  3. 1 generation backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
  4. This deviceK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
  5. Descendant · cites it directly · 9 of its ownK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
  6. Descendant · 2 generations on · 4 of its ownK153053 Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015
  7. Descendant · 3 generations on · 2 of its ownK161803 Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK182337 HYBRID GuidewireBalt USA, LLC · 2018
  9. Descendant · cites it directly · 1 of its ownK093397 Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc. · 2009

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2009: 12014: 12015: 12016: 22018: 12019: 12020: 32026: 2
2009high 3 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 12 · See all
  • K133725Traxcess 14 GuidewireMicroVention, Inc. · 2014 · cites it directly9descendants
  • K153053Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015 · 2 generations on4descendants
  • K161803Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · 3 generations on2descendants
  • K182337HYBRID GuidewireBalt USA, LLC · 2018 · 2 generations on1descendant
  • K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc. · 2009 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953533Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp.1995—
−2K961445Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp.1996—
−1K063695Runthrough NSTerumo Medical Corp.20071
0 (this device)K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.2008—
+1K133725Traxcess 14 GuidewireMicroVention, Inc.2014—
+2K153053Traxcess Pro 14 GuidewireMicroVention, Inc.2015—
+3K161803Traxcess .007 Mini GuidewireMicroVention, Inc.20161
+2K182337HYBRID GuidewireBalt USA, LLC2018—
+1K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201410
201510
201620
201810
201910
202030
202620
FIG. 1 — Lineage of K080863, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K063695Runthrough NS
Summary page 1
…y: MicroVention, Inc. 75 Columbia, Suite A Aliso Viejo, CA 92656 Contact: Kevin E. Daly Predicate Runthrough NS (K063695) Devices: Transend EX Platinum Guidewire (K971254) Radifocus Glidewire GT with Gold Coil (K955801) De…
Terumo Medical Corp.20071
*K971254Transend EX Platinum Guidewire
Summary page 1
…ite A Aliso Viejo, CA 92656 Contact: Kevin E. Daly Predicate Runthrough NS (K063695) Devices: Transend EX Platinum Guidewire (K971254) Radifocus Glidewire GT with Gold Coil (K955801) Device Description: The Traxcess 0.014" Hydrophilic Guidewire…
Boston Scientific Corp1997—
*K955801Radifocus Glidewire GT with Gold Coil,Glidewire Gold
Summary page 1
…vin E. Daly Predicate Runthrough NS (K063695) Devices: Transend EX Platinum Guidewire (K971254) Radifocus Glidewire GT with Gold Coil (K955801) Device Description: The Traxcess 0.014" Hydrophilic Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol…
Terumo Medical Corp.1996—

Also cleared against K063695: 2 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133725Traxcess 14 GuidewireMicroVention, Inc.20149
K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc.20091

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?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K133725 (MicroVention, Inc., 2014) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K063695.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The Traxcess 0.014" Hydrophilic Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

Indications for use as stated in the FDA summary.

Also cleared against K063695

2 other devices cite the same predicate.

  • K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
  • K080563Runthrough NS Extension WireTerumo Medical Corp. · 2008

More from MicroVention, Inc.

136 FDA decisions under this applicant name. See the company

  • P170013/S013Intraluminal Support Device LVIS/LVIS Jr./LVIS EVOMicroVention, Inc. · 2026
  • P210030/S002Roadsaver/CASPER Carotid Stent SystemMicroVention, Inc. · 2026
  • P170032/S022Woven EndoBridge (WEB) Aneurysm Embolization SystemMicroVention, Inc. · 2026
  • P170032/S021Woven EndoBridge (WEB) Aneurysm Embolization SystemMicroVention, Inc. · 2026
  • P170032/S019Woven EndoBridge Aneurysm Embolization (WEB) SystemMicroVention, Inc. · 2026

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K080863 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080863: Traxcess 0.014 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/K080863

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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