510(k) · Cleared

Recalled · Class II · 2013

Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189

K013789510(k) SpecialCleared Dec 6, 200122-day reviewClass II21 CFR 870.1250Recalls 2

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

Boston Scientific, Target · DQY Catheter, Percutaneous

Cleared on Dec 6, 2001 as substantially equivalent to K994155 (Boston Scientific, Target, 2000) and 1 other predicate after a 22-day review. Its family tree reaches back 2 generations to 1996. 81 later devices descend from it. It has been recalled 2 times.

Decided: Dec 6, 2001
Review: 22 days
Class: Class II
Product code: DQY
Recalls: 2
Predicates: 2

Its longest line of descent runs back 2 generations to K960806 (1996). 3 ancestors in all, the oldest K925813 (1994). 81 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
1 generation backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
This deviceK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001
Descendant · cites it directly · 39 of its ownK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
Descendant · cites it directly · 25 of its ownK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
Descendant · cites it directly · 20 of its ownK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
Descendant · 2 generations on · 19 of its ownK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
Descendant · 2 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2003high 7 (2019) · low 1 (2003)2026

Most influential descendants

Showing 5 of 81 · See all

K083343Headway 17 MicrocatheterMicroVention, Inc. · 2008 · cites it directly39descendants
K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · cites it directly25descendants
K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003 · cites it directly20descendants
K093160Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009 · 2 generations on19descendants
K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 2 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K960806	Turbo Tracker	Target Therapeutics	1996	—
−1	K994155	Excelsior 1018 Microcatheter	Boston Scientific, Target	2000	—
0 (this device)	K013789	Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189	Boston Scientific, Target	2001	—
+1	K083343	Headway 17 Microcatheter	MicroVention, Inc.	2008	—
+1	K042568	Excelsior 1018 and SL-10 Microcatheters	Boston Scientific Corp	2004	7
+1	K032494	PVS 1700 Steerable Delivery System Microcatheter	Precision Vascular Systems, Inc.	2003	—
+2	K093160	Headway 21 Microcatheter, Model: MC212150S	MicroVention, Inc.	2009	—
+2	K041123	Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703	Kerberos Proximal Solutions, Inc.	2004	—

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
2003	1	0
2004	3	0
2005	2	0
2006	2	0
2007	4	0
2008	3	0
2009	1	0
2010	2	0
2011	1	0
2012	6	0
2013	4	0
2014	2	0
2015	4	0
2016	2	0
2017	3	0
2018	3	0
2019	7	0
2020	4	0
2021	2	0
2022	5	0
2023	6	0
2024	5	0
2025	5	0
2026	4	0

FIG. 1 — Lineage of K013789, 1996–2026Source: 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? (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	Applicant	Decided	Recalls
*	K994155	Excelsior 1018 Microcatheter Summary page 1 …ior™SL-10 Microcatheter d. Common Name Microcatheter e. Classification Name Percutaneous Catheter (21 CFR Section 870.1250) f. Identification of Predicate Devices -K994155 Excelsior 1018 Microcatheter - 03 August 2000 K925813 Tracker-10 23 March 1994 Microcatheter Special 510(k): Device Modification…	Boston Scientific, Target	2000	—
*	K925813	Diagnostic Intravascular Catheter Summary page 1 …e. Classification Name Percutaneous Catheter (21 CFR Section 870.1250) f. Identification of Predicate Devices -K994155 Excelsior 1018 Microcatheter - 03 August 2000 K925813 Tracker-10 23 March 1994 Microcatheter Special 510(k): Device Modification Boston Scientific Target, Excelsior SL-10 Microcathete…	Target Therapeutics	1994	—

Also cleared against K994155: 3 other devices →

What descends from it? (81)

See all 81

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

Number	Device	Applicant	Decided	Descendants
K083343	Headway 17 Microcatheter	MicroVention, Inc.	2008	39
K042568	Excelsior 1018 and SL-10 Microcatheters	Boston Scientific Corp	2004	25
K032494	PVS 1700 Steerable Delivery System Microcatheter	Precision Vascular Systems, Inc.	2003	20
K241158	ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3	Asahi Intecc Co., Ltd.	2024	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 4, 2013	Class II	Z-0498-2014	Software Manufacturing/Software Deployment	Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Oct 7, 2008	Not classified	Z-0627-2009	Package design/selection	Packaging issue may result in failure to maintain sterile barrier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K083343 (MicroVention, Inc., 2008) has gone furthest, with 39 descendants of its own.
3 other devices also cite its predicate K994155.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Excelsior SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

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

https://510kreport.com/device/K013789 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013789: Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013789

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026