510(k) · Cleared

Cleared

Ultra -Thin SDS Balloon Dilatation Catheter

K011889510(k) TraditionalCleared Dec 21, 2001186-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

Boston Scientific Corp · DQY Catheter, Percutaneous

Cleared on Dec 21, 2001 as substantially equivalent to K972744 (Boston Scientific Corp, 1997) after a 186-day review. Its family tree reaches back 1 generation to 1997. 20 later devices descend from it.

Decided: Dec 21, 2001
Review: 186 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K972744 (1997). 20 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK972744 Courier ST Balloon Dilatation CatheterBoston Scientific Corp · 1997
This deviceK011889 Ultra -Thin SDS Balloon Dilatation CatheterBoston Scientific Corp · 2001
Descendant · cites it directly · 14 of its ownK082339 Enabler-P Support CatheterEndocross, Ltd. · 2008
Descendant · 2 generations on · 12 of its ownK083833 Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009
Descendant · 2 generations on · 9 of its ownK092174 Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009
Descendant · 3 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
Descendant · cites it directly · 4 of its ownK021630 Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp · 2002

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2002high 4 (2016) · low 0 (2004)2026

Most influential descendants

Showing 5 of 20 · See all

K082339Enabler-P Support CatheterEndocross, Ltd. · 2008 · cites it directly14descendants
K083833Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009 · 2 generations on12descendants
K092174Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009 · 2 generations on9descendants
K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 3 generations on8descendants
K021630Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp · 2002 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972744	Courier ST Balloon Dilatation Catheter	Boston Scientific Corp	1997	—
0 (this device)	K011889	Ultra -Thin SDS Balloon Dilatation Catheter	Boston Scientific Corp	2001	—
+1	K082339	Enabler-P Support Catheter	Endocross, Ltd.	2008	—
+2	K083833	Enabler-P Catheter, 1000 Part Number:1160	Endocross, Ltd.	2009	—
+2	K092174	Enabler-P Catheter System, Model 3000	Endocross, Ltd.	2009	—
+3	K121763	Multicross Support Catheter	Roxwood Medical, Inc.	2012	—
+1	K021630	Boston Scientific Express Biliary LD Premounted Stent System	Boston Scientific Corp	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2008	1	0
2009	2	0
2012	2	0
2014	2	0
2015	2	0
2016	4	0
2017	2	0
2022	1	0

FIG. 1 — Lineage of K011889, 1997–2022Source: 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

Get a 510(k) Report

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
*	K972744	Courier ST Balloon Dilatation Catheter Summary page 1 …he predicate device for the Ultra-Thin SDS Balloon Dilatation Catheter: Boston Scientific Corporation -- Marshal (submitted as Courier ST) Balloon Dilatation Catheter (K972744 The device mentioned above has been determined substantially equivalent by FDA. 100068 KOLLBBY p. 2 /2 Ultra-T…	Boston Scientific Corp	1997	—

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K082339	Enabler-P Support Catheter	Endocross, Ltd.	2008	14
K021630	Boston Scientific Express Biliary LD Premounted Stent System	Boston Scientific Corp	2002	4

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?

Its one ancestor has no recall.
Of its descendants, K082339 (Endocross, Ltd., 2008) has gone furthest, with 14 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)	—

What is it indicated for?

Ultra-Thin SDS Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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/K011889 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011889: Ultra -Thin SDS Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011889

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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