510(k) · Cleared

Cleared

Headway 21 Microcatheter, Model: MC212150S

K093160510(k) SpecialCleared Nov 5, 200930-day reviewClass II21 CFR 870.1250

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

MicroVention, Inc. · DQY Catheter, Percutaneous

Cleared on Nov 5, 2009 as substantially equivalent to K083343 (MicroVention, Inc., 2008) after a 30-day review. Its family tree reaches back 4 generations to 1996. 19 later devices descend from it.

Decided: Nov 5, 2009
Review: 30 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K960806 (1996). 5 ancestors in all, the oldest K925813 (1994). 19 later devices descend from it, 5 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 backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
This deviceK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
Descendant · cites it directly · 8 of its ownK110813 Headway 27 MicrocatheterMicroVention, Inc. · 2011
Descendant · 2 generations on · 5 of its ownK142449 Headway 27 MicrocatheterMicroVention, Inc. · 2015
Descendant · 3 generations on · 3 of its ownK192625 PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019
Descendant · cites it directly · 3 of its ownK172014 Wedge MicrocatheterMicroVention, Inc. · 2018
Descendant · 4 generations on · 2 of its ownK231600 SENDERO MicrocatheterOkami Medical, Inc. · 2023

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2011high 3 (2019) · low 0 (2012)2026

Most influential descendants

Showing 5 of 19 · See all

K110813Headway 27 MicrocatheterMicroVention, Inc. · 2011 · cites it directly8descendants
K142449Headway 27 MicrocatheterMicroVention, Inc. · 2015 · 2 generations on5descendants
K192625PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019 · 3 generations on3descendants
K172014Wedge MicrocatheterMicroVention, Inc. · 2018 · cites it directly3descendants
K231600SENDERO MicrocatheterOkami Medical, Inc. · 2023 · 4 generations on2descendants

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	K083343	Headway 17 Microcatheter	MicroVention, Inc.	2008	—
0 (this device)	K093160	Headway 21 Microcatheter, Model: MC212150S	MicroVention, Inc.	2009	—
+1	K110813	Headway 27 Microcatheter	MicroVention, Inc.	2011	—
+2	K142449	Headway 27 Microcatheter	MicroVention, Inc.	2015	—
+3	K192625	PG Pro Microcatheter	MicroVention, Inc. A TERUMO Group Company	2019	—
+1	K172014	Wedge Microcatheter	MicroVention, Inc.	2018	—
+4	K231600	SENDERO Microcatheter	Okami Medical, Inc.	2023	—

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
2011	1	0
2013	1	0
2015	2	0
2017	2	0
2018	1	0
2019	3	0
2022	2	0
2023	2	0
2024	3	0
2025	2	0

FIG. 1 — Lineage of K093160, 1996–2025Source: 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
*	K083343	Headway 17 Microcatheter Summary page 1 …Tustin, California U.S.A. Contact: Naomi Gong Predicate Device: Number Description Clearance Date K083343 Headway 17 Microcatheter December 4, 2008 Device Description: The Headway 21 Microcatheter i…	MicroVention, Inc.	2008	—

Also cleared against K083343: 5 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K110813	Headway 27 Microcatheter	MicroVention, Inc.	2011	8
K172014	Wedge Microcatheter	MicroVention, Inc.	2018	3
K150894	VIA 21 Microcatheter	Sequent Medical, Inc.	2015	2
K203842	Bendit21 Microcatheter	Bend IT Technologies, Ltd.	2022	1
K182487	CerusEndo Microcatheter	Cerus Endovascular, Inc.	2019	0

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 13 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K110813 (MicroVention, Inc., 2011) has gone furthest, with 8 descendants of its own.
5 other devices also cite its predicate K083343.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Headway 21 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils:

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093160 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093160: Headway 21 Microcatheter, Model: MC212150S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093160

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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