510(k) · Cleared

Recalled · 2003

Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter

K021735510(k) TraditionalCleared Aug 8, 200272-day reviewClass II21 CFR 870.1250Recalls 23

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

Boston Scientific Scimed, Inc. · DQY Catheter, Percutaneous

Cleared on Aug 8, 2002 as substantially equivalent to K001134 (Boston Scientific Corp, 2000) after a 72-day review. Its family tree reaches back 1 generation to 2000. 165 later devices descend from it. It has been recalled 23 times.

Decided: Aug 8, 2002
Review: 72 days
Class: Class II
Product code: DQY
Recalls: 23
Predicates: 1

Its longest line of descent runs back 1 generation to K001134 (2000). 165 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
This deviceK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002
Descendant · cites it directly · 164 of its ownK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
Descendant · cites it directly · 133 of its ownK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
Descendant · 2 generations on · 96 of its ownK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
Descendant · 2 generations on · 62 of its ownK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
Descendant · 3 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled

Showing 5 of 165 descendants. See all descendants

Descendants cleared per year

2005high 14 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 165 · See all

K050389Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005 · cites it directly164descendants
K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005 · cites it directly133descendants
K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · 2 generations on96descendants
K053118Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxBoston Scientific Corp · 2005 · 2 generations on62descendants
K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 3 generations on44descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001134	Gazelle Balloon Dilatation Catheter	Boston Scientific Corp	2000	—
0 (this device)	K021735	Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter	Boston Scientific Scimed, Inc.	2002	—
+1	K050389	Ultra-Soft SV Balloon Dilatation Catheter	Boston Scientific Corp	2005	—
+1	K053116	Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx	Boston Scientific Corp	2005	—
+2	K072283	Dorado Pta Balloon Dilatation Catheter	Bard Peripheral Vascular, Inc.	2007	15
+2	K053118	Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx	Boston Scientific Corp	2005	—
+3	K083657	Conquest Pta Balloon Dilatation Catheter	C.R. Bard, Inc.	2008	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2007	3	0
2008	5	0
2009	3	0
2010	4	0
2011	12	0
2012	14	0
2013	9	0
2014	13	0
2015	13	0
2016	12	0
2017	7	0
2018	6	0
2019	5	0
2020	10	0
2021	4	0
2022	12	0
2023	3	0
2024	12	0
2025	7	0
2026	8	0

FIG. 1 — Lineage of K021735, 2000–2026Source: 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? (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
*	K001134	Gazelle Balloon Dilatation Catheter	Boston Scientific Corp	2000	—

Also cleared against K001134: 1 other device →

What descends from it? (165)

See all 165

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

Number	Device	Applicant	Decided	Descendants
K050389	Ultra-Soft SV Balloon Dilatation Catheter	Boston Scientific Corp	2005	164
K053116	Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx	Boston Scientific Corp	2005	133
K162350	Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…	Boston Scientific Corporation	2016	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 1, 2003	Not classified	Z-1118-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1120-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1110-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1113-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1106-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1112-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1111-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1097-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1096-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1098-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1108-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1119-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1103-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1117-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1100-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1115-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1099-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1114-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1105-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1104-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1101-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1116-03	Other	Some of the product pouches have holes in the seals.
Jul 1, 2003	Not classified	Z-1107-03	Other	Some of the product pouches have holes in the seals.

The 5 latest of 23 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K050389 (Boston Scientific Corp, 2005) has gone furthest, with 164 descendants of its own.
1 other device also cites its predicate K001134.

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 Ultra-soft SV 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 as stated in the FDA summary.

https://510kreport.com/device/K021735 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021735: Boston Scientific Ultra-Soft SV Balloon 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/K021735

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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