510(k) Report

510(k) · Cleared

Cleared

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

K183608510(k) TraditionalCleared Mar 22, 201986-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 · MOF Guide, Wire, Catheter, Neurovasculature

Cleared on Mar 22, 2019 as substantially equivalent to K173235 (Scientia Vascular, LLC, 2018) after an 86-day review. Its family tree reaches back 3 generations to 2000. 13 later devices descend from it.

Decided
Mar 22, 2019
Review
86 days
Class
Class II
Product code
MOF
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K002212 (2000). 13 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2023: 3 descendants cleared2019: 1 descendant cleared2024: 1 descendant cleared2025: 2 descendants cleared2026: 6 descendants 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 · recalledK173235 · Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile · Scientia Vascular, LLC · 2018200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants 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 · Scientia Vascular, LLC · 2018K032146 · 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 · 3 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
  2. 2 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
  3. 1 generation backK173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire…Scientia Vascular, LLC · 2018
  4. This deviceK183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
  5. Descendant · cites it directly · 12 of its ownK192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
  6. Descendant · cites it directly · 5 of its ownK231954 Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc. · 2023
  7. Descendant · 2 generations on · 5 of its ownK222437 Aristotle Colossus GuidewireScientia Vascular, Inc. · 2023
  8. Descendant · 2 generations on · 2 of its ownK243938 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24…Scientia Vascular, Inc. · 2025
  9. Descendant · 2 generations on · 1 of its ownK233791 Drivewire 24 GuidewireRapid-Medical, Ltd. · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2019: 12023: 32024: 12025: 22026: 6
2019high 6 (2026) · low 0 (2020)2026

Most influential descendants

Showing 5 of 13 · See all
  • K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…Scientia Vascular, LLC · 2019 · cites it directly12descendants
  • K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc. · 2023 · cites it directly5descendants
  • K222437Aristotle Colossus GuidewireScientia Vascular, Inc. · 2023 · 2 generations on5descendants
  • K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc. · 2025 · 2 generations on2descendants
  • K233791Drivewire 24 GuidewireRapid-Medical, Ltd. · 2024 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002212Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc.2000—
−2K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc.20031
−1K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm…Scientia Vascular, LLC2018—
0 (this device)K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm…Scientia Vascular, LLC2019—
+1K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm…Scientia Vascular, LLC2019—
+1K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.2023—
+2K222437Aristotle Colossus GuidewireScientia Vascular, Inc.2023—
+2K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom…Scientia Vascular, Inc.2025—
+2K233791Drivewire 24 GuidewireRapid-Medical, Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202330
202410
202520
202660
FIG. 1 — Lineage of K183608, 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 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. #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 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
*K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…
Summary page 4
…tion Name Catheter Guide Wire per 21 CFR 870.1330 Primary Product Code: MOF Secondary Product Code: DQX Predicate Device: Aristotle 14 Guidewire (K173235) Pg. 1 Scientia Vascular LLC Traditi…
Scientia Vascular, LLC2018—

Also cleared against K173235: 5 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…Scientia Vascular, LLC201912
K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.20235
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…Scientia Vascular, LLC20231

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 19 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K192783 (Scientia Vascular, LLC, 2019) has gone furthest, with 12 descendants of its own.
  • 5 other devices also cite its predicate K173235.

How does its category compare?

All MOF devices

MOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · MOF

11so far in 2026, the most since 2007

2011: 22014: 22015: 32016: 42017: 12018: 22019: 42020: 42022: 12023: 42024: 22025: 52026 (partial year): 11
2007high 11 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOF

172in 2025

2015: 133 days median2016: 61 days median2019: 58 days median2020: 36 days median2023: 199 days median2025: 172 days median2026 (partial year): 192 days median
2007high 199 (2023) · low 36 (2020)2026

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

2008: 12012: 22013: 22015: 52016: 32017: 152018: 112019: 122020: 182021: 392022: 922023: 912024: 952025: 135
2007high 135 (2025) · low 0 (2007)2025

MAUDE reports naming product code MOF, 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
20070—00
20080—01
20090—00
20100—00
20112—00
20120—02
20130—02
20142—00
2015313305
201646103
20171—015
20182—011
2019458012
2020436018
20210—039
20221—092
20234199091
20242—095
202551720135
2026111920—

What is it indicated for?

The Aristotle 18 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 K173235

5 other devices cite the same predicate.

  • K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc. · 2026
  • K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle…Scientia Vascular, Inc. · 2025
  • K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14…Scientia Vascular, LLC · 2023
  • K201760Zoom 14 GuidewireScientia Vascular, LLC · 2020
  • K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire…Scientia Vascular, LLC · 2018

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
  • K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire…Scientia Vascular, LLC · 2018

Recent decisions in MOF

The MOF category page

  • K254181Aristotle 65 MacrowireScientia Vascular · 2026
  • K26075135 Helix GuidewirePiraeus Medical, Inc. · 2026
  • K262424Willow 12 GuidewireArbor Endovascular, LLC · 2026
  • K260223Aristotle Mini GuidewireScientia Vascular, Inc. · 2026
  • K254006Drivewire 35 GuidewireRapid Medical Ltd. · 2026

https://510kreport.com/device/K183608 · printed Nov 4, 2026

Cite this page

510(k) Report. “K183608: Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183608

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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