510(k) Report

510(k) · Cleared

Cleared

Plato MICROCATH 27B Microcatheter

K143398510(k) TraditionalCleared Jun 26, 2015212-day reviewClass II21 CFR 870.1200

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

Scientia Vascular, LLC · DQO Catheter, Intravascular, Diagnostic

Cleared on Jun 26, 2015 as substantially equivalent to K111490 (Ev3, Inc., 2011) and 2 other predicates after a 212-day review. Its family tree reaches back 3 generations to 1998.

Decided
Jun 26, 2015
Review
212 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K974473 (1998). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2009: 1 other ancestorK974473 · Easy Rider Micro Catheter · Micro Therapeutics, Inc. · 1998K993672 · Rebar Micro Catheter, Models 105-5080, 105-5086 · Micro Therapeutics, Inc. · 2000K121734 · Plato Microcath 27 Microcatheter · Scientia Vascular, LLC · 201219952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors K121734 · Plato Microcath 27 Microcatheter · Scientia Vascular, LLC · 2012K993672 · Rebar Micro Catheter, Models 105-5080, 105-5086 · Micro Therapeutics, Inc. · 2000K974473 · Easy Rider Micro Catheter · Micro Therapeutics, Inc. · 19980
  1. Root · 3 generations backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
  2. 2 generations backK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
  3. 1 generation backK121734 Plato Microcath 27 MicrocatheterScientia Vascular, LLC · 2012
  4. This deviceK143398 Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K974473Easy Rider Micro CatheterMicro Therapeutics, Inc.1998—
−2K993672Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc.2000—
−1K121734Plato Microcath 27 MicrocatheterScientia Vascular, LLC2012—
0 (this device)K143398Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
FIG. 1 — Lineage of K143398, 1998–2015Source: 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 DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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
*K111490Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…
Summary page 5
…fication Name: Diagnostic Intravascular Catheter per 21 CFR 870.1200, DQO Continuous Flush Catheter per 21 CFR 870.1210, KRA Predicate Devices: ev3 Marksman™ Catheter, K 111490, K091559 Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter, K121734 Device Description: The Plato MICROCATH® 27B Microcath…
Ev3, Inc.2011—
*K091559Marksmann Catheter
Summary page 5
…ame: Diagnostic Intravascular Catheter per 21 CFR 870.1200, DQO Continuous Flush Catheter per 21 CFR 870.1210, KRA Predicate Devices: ev3 Marksman™ Catheter, K 111490, K091559 Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter, K121734 Device Description: The Plato MICROCATH® 27B Microcatheter is a…
Chestnut Medical Technologies, Inc.2009—
*K121734Plato Microcath 27 Microcatheter
Summary page 5
…ontinuous Flush Catheter per 21 CFR 870.1210, KRA Predicate Devices: ev3 Marksman™ Catheter, K 111490, K091559 Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter, K121734 Device Description: The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter constructed with a flexible polymer s…
Scientia Vascular, LLC2012—

Also cleared against K111490: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
  • None of the 5 ancestors has a recall.
  • 2 other devices also cite its predicate K111490.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The catheter is not intended for use in either the coronary or neuro vasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K111490

2 other devices cite the same predicate.

  • K170406Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2017
  • K152625MMS Guide CatheterMicro Medical Solutions, Inc. · 2016

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 DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K143398 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143398: Plato MICROCATH 27B Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143398

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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