510(k) · Cleared

Recalled · Class II · 2023

Plato 17 Microcatheter

K210601510(k) TraditionalCleared Apr 28, 202158-day reviewClass II21 CFR 870.1250Recalls 1

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

Scientia Vascular, LLC · DQY Catheter, Percutaneous

Cleared on Apr 28, 2021 as substantially equivalent to K042568 (Boston Scientific Corp, 2004) after a 58-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it. It has been recalled once.

Decided: Apr 28, 2021
Review: 58 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 1

Its longest line of descent runs back 4 generations to K960806 (1996). 5 ancestors in all, the oldest K925813 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
3 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
2 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
1 generation backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
This deviceK210601 Plato 17 MicrocatheterScientia Vascular, LLC · 2021
Descendant · cites it directly · 0 of its ownK223560 Plato 17 MicrocatheterScientia Vascular, Inc. · 2023 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K223560Plato 17 MicrocatheterScientia Vascular, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K960806	Turbo Tracker	Target Therapeutics	1996	—
−3	K994155	Excelsior 1018 Microcatheter	Boston Scientific, Target	2000	—
−2	K013789	Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189	Boston Scientific, Target	2001	2
−1	K042568	Excelsior 1018 and SL-10 Microcatheters	Boston Scientific Corp	2004	7
0 (this device)	K210601	Plato 17 Microcatheter	Scientia Vascular, LLC	2021	—
+1	K223560	Plato 17 Microcatheter	Scientia Vascular, Inc.	2023	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K210601, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K042568	Excelsior 1018 and SL-10 Microcatheters Summary page 4 …Cardiovascular Device Class: Class II device per 21 CFR 870.1250 Predicate Device: ExcelsiorTM SL-10 Pre-Shaped Microcatheter (K042568, cleared 10/15/2004) Reference Device Excelsior XT-17 Microcatheter (K142565, c…	Boston Scientific Corp	2004	7
†	K142565	Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17…	Stryker Neurovascular	2014	—

Also cleared against K042568: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K223560	Plato 17 Microcatheter	Scientia Vascular, Inc.	2023	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 1, 2023	Class II	Z-1249-2023	Device Design	Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K223560 (Scientia Vascular, Inc., 2023) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K042568.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K210601 · printed Nov 4, 2026

Cite this page

510(k) Report. “K210601: Plato 17 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210601

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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