510(k) Report

510(k) · Cleared

Cleared

Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile

K173235510(k) TraditionalCleared Jan 22, 2018109-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

Scientia Vascular, LLC · DQX Wire, Guide, Catheter

Cleared on Jan 22, 2018 as substantially equivalent to K032146 (Precision Vascular Systems, Inc., 2003) after a 109-day review. Its family tree reaches back 2 generations to 2000. 16 later devices descend from it.

Decided
Jan 22, 2018
Review
109 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K002212 (2000). 16 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2025: 2 descendants cleared2018: 1 descendant cleared2019: 2 descendants cleared2023: 3 descendants cleared2026: 6 descendants cleared2024: 1 descendant clearedK002212 · Mirage Hydrophilic Guidewire, Model 103-0608 · Micro Therapeutics, Inc. · 2000K032146 · PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires · Precision Vascular Systems, Inc. · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants K032146 · PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires · Precision Vascular Systems, Inc. · 2003 · recalledK002212 · Mirage Hydrophilic Guidewire, Model 103-0608 · Micro Therapeutics, Inc. · 20000
  1. Root · 2 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
  2. 1 generation backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
  3. This deviceK173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire…Scientia Vascular, LLC · 2018
  4. Descendant · cites it directly · 13 of its ownK183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
  5. Descendant · 2 generations on · 12 of its ownK192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
  6. Descendant · cites it directly · 6 of its ownK201760 Zoom 14 GuidewireScientia Vascular, LLC · 2020
  7. Descendant · 2 generations on · 5 of its ownK231954 Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc. · 2023
  8. Descendant · 3 generations on · 5 of its ownK222437 Aristotle Colossus GuidewireScientia Vascular, Inc. · 2023

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2018: 12019: 22020: 12023: 32024: 12025: 22026: 6
2018high 6 (2026) · low 0 (2021)2026

Most influential descendants

Showing 5 of 16 · See all
  • K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard…Scientia Vascular, LLC · 2019 · cites it directly13descendants
  • K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…Scientia Vascular, LLC · 2019 · 2 generations on12descendants
  • K201760Zoom 14 GuidewireScientia Vascular, LLC · 2020 · cites it directly6descendants
  • K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc. · 2023 · 2 generations on5descendants
  • K222437Aristotle Colossus GuidewireScientia Vascular, Inc. · 2023 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002212Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc.2000—
−1K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc.20031
0 (this device)K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm…Scientia Vascular, LLC2018—
+1K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm…Scientia Vascular, LLC2019—
+2K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm…Scientia Vascular, LLC2019—
+1K201760Zoom 14 GuidewireScientia Vascular, LLC2020—
+2K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.2023—
+3K222437Aristotle Colossus GuidewireScientia Vascular, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201920
202010
202330
202410
202520
202660
FIG. 1 — Lineage of K173235, 2000–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires
Summary page 4
…Guidewire Classification Name Catheter Guide Wire per 21 CFR 870.1330 Product Code: DQX Predicate Device: PVS 1300 Synchro® 0.014” Guidewire (K032146) Pg. 1 Scientia Vascular LLC…
Precision Vascular Systems, Inc.20031

Also cleared against K032146: 3 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard…Scientia Vascular, LLC201913
K201760Zoom 14 GuidewireScientia Vascular, LLC20206
K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20252
K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo…Scientia Vascular, LLC20182
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…Scientia Vascular, LLC20231
K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20260

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 18 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K183608 (Scientia Vascular, LLC, 2019) has gone furthest, with 13 descendants of its own.
  • 3 other devices also cite its predicate K032146.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K032146

3 other devices cite the same predicate.

  • K252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd. · 2026
  • K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 200613 recalls
  • K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 20056 recalls

More from Scientia Vascular, LLC

10 FDA decisions under this applicant name. See the company

  • K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14…Scientia Vascular, LLC · 2023
  • K210601Plato 17 MicrocatheterScientia Vascular, LLC · 20211 recall
  • K201760Zoom 14 GuidewireScientia Vascular, LLC · 2020
  • K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
  • K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18…Scientia Vascular, LLC · 2019

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/K173235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173235: Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173235

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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