510(k) · Cleared

Cleared

Cordis M3 Pta Dilatation Catheter

K003920510(k) AbbreviatedCleared Jun 15, 2001178-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

Cordis Corp. · DQY Catheter, Percutaneous

Cleared on Jun 15, 2001 after a 178-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.

Decided: Jun 15, 2001
Review: 178 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 0

66 later devices descend from it, 2 citing it directly.

This deviceK003920 Cordis M3 Pta Dilatation CatheterCordis Corp. · 2001
Descendant · cites it directly · 65 of its ownK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
Descendant · 2 generations on · 38 of its ownK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
Descendant · 3 generations on · 37 of its ownK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
Descendant · 2 generations on · 36 of its ownK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
Descendant · 3 generations on · 34 of its ownK082059 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2001high 7 (2015) · low 0 (2002)2026

Most influential descendants

Showing 5 of 66 · See all

K013581Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001 · cites it directly65descendants
K050629Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005 · 2 generations on38descendants
K072225Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · 3 generations on37descendants
K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · 2 generations on36descendants
K082059Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008 · 3 generations on34descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003920	Cordis M3 Pta Dilatation Catheter	Cordis Corp.	2001	—
+1	K013581	Cordis Aviator Peripheral Dilatation Catheter	Cordis, A Johnson & Johnson Co.	2001	—
+2	K050629	Angiosculpt Scoring Balloon Catheter	Angioscore, Inc.	2005	—
+3	K072225	Angiosculpt Pta Scoring Balloon Catheter	Angioscore, Inc.	2007	5
+2	K080151	Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039	Angioscore, Inc.	2008	5
+3	K082059	Angiosculpt Pta Scoring Balloon Catheter	Angioscore, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	2	0
2007	3	0
2008	4	0
2009	1	0
2010	3	0
2011	3	0
2012	3	0
2013	1	0
2014	2	0
2015	7	0
2016	4	0
2017	2	0
2018	2	0
2019	2	0
2020	4	0
2021	3	0
2022	7	0
2024	6	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K003920, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K013581	Cordis Aviator Peripheral Dilatation Catheter	Cordis, A Johnson & Johnson Co.	2001	65
K050645	Cordis Amiia .014 Pta Balloon Catheter	Cordis Corp.	2005	25

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?

Of its descendants, K013581 (Cordis, A Johnson & Johnson Co., 2001) has gone furthest, with 65 descendants of its own.

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)	—

https://510kreport.com/device/K003920 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003920: Cordis M3 Pta Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003920

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026