510(k) · Cleared
ClearedPlato MICROCATH 27B Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientia Vascular, LLC · DQO Catheter, Intravascular, Diagnostic
Cleared on Apr 18, 2017 as substantially equivalent to K111490 (Ev3, Inc., 2011) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Apr 18, 2017
- Review
- 67 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K091559 (2009). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK091559 Marksmann CatheterChestnut Medical Technologies, Inc. · 2009
- This deviceK170406 Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091559 | Marksmann Catheter | Chestnut Medical Technologies, Inc. | 2009 | — |
| 0 (this device) | K170406 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…Summary page 4…ode: Continuous Flush Catheter per 21 CFR 870.1210, KRA Percutaneous Catheter per 21 CFR 870.1250, DQY Predicate Device: ev3 Marksman™ Catheter (K111490, K091559) Reference Device: Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter (K143398)… | 2011 |
| * | K091559 | Marksmann CatheterSummary page 4…ntinuous Flush Catheter per 21 CFR 870.1210, KRA Percutaneous Catheter per 21 CFR 870.1250, DQY Predicate Device: ev3 Marksman™ Catheter (K111490, K091559) Reference Device: Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter (K143398)… | 2009 |
| † | K143398 | Plato MICROCATH 27B Microcatheter | 2015 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K111490.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic agents to the peripheral and neurovascular systems. The catheter is also intended for the introduction of therapeutic agents to the peripheral system. The catheter is not intended for use in the coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170406: 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/K170406
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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