510(k) · Cleared

Cleared

Gore Tri-Lobe Balloon Catheter

K033670510(k) TraditionalCleared May 5, 2004163-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

W. L. Gore & Associates, Inc. · DQY Catheter, Percutaneous

Cleared on May 5, 2004 as substantially equivalent to K003495 (Guidant Cardiac and Vascular Surgery, 2001) and 2 other predicates after a 163-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.

Decided: May 5, 2004
Review: 163 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K003495 (2001). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
This deviceK033670 Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2004
Descendant · cites it directly · 3 of its ownK110891 The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive…LeMaitre Vascular, Inc. · 2011
Descendant · 2 generations on · 2 of its ownK121839 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
Descendant · cites it directly · 2 of its ownK081799 Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2008
Descendant · 2 generations on · 1 of its ownK123531 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK243184 SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008high 2 (2012) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all

K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2011 · cites it directly3descendants
K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012 · 2 generations on2descendants
K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2008 · cites it directly2descendants
K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012 · 2 generations on1descendant
K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003495	Ancure Lliac Balloon Catheter	Guidant Cardiac and Vascular Surgery	2001	—
0 (this device)	K033670	Gore Tri-Lobe Balloon Catheter	W. L. Gore & Associates, Inc.	2004	—
+1	K110891	The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling…	LeMaitre Vascular, Inc.	2011	—
+2	K121839	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2012	—
+1	K081799	Gore Tri-Lobe Balloon Catheter	W. L. Gore & Associates, Inc.	2008	—
+2	K123531	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2012	—
+2	K243184	SAT CenterFlow Molding Balloon Catheter (IN20-00313)	Strait Access Technologies Holdings	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2012	2	0
2013	1	0
2025	2	0

FIG. 1 — Lineage of K033670, 2001–2025Source: 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? (3)

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
*	K003495	Ancure Lliac Balloon Catheter Summary page 2 …intended use. * ANCURE® Iliac Balloon Catheter (Guidant Cardiac & Vascular Surgery (C&VS), Menlo Park, CA) - K003495 * EqualizerT M Balloon Catheter (Boston Scientific Corporation, Natick, MA) - K02…	Guidant Cardiac and Vascular Surgery	2001	—
*	K021721	Equalizer Balloon Catheter Summary page 2 …(C&VS), Menlo Park, CA) - K003495 * EqualizerT M Balloon Catheter (Boston Scientific Corporation, Natick, MA) - K021721 : LDOB Occlusion Balloon Catheter (COOK INCORPORATED, Bloomington, IN) - K002286…	Boston Scientific Corp	2002	4
*	K002286	Ldob Occlusion Balloon Catheter Summary page 2 …, Natick, MA) - K021721 : LDOB Occlusion Balloon Catheter (COOK INCORPORATED, Bloomington, IN) - K002286 Labeling, packaging and sterilization of the GORE Tri-Lobe Balloon Catheter is substantially equivale…	Cook, Inc.	2001	—

Also cleared against K003495: 2 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K110891	The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2011	3
K081799	Gore Tri-Lobe Balloon Catheter	W. L. Gore & Associates, Inc.	2008	2

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K110891 (LeMaitre Vascular, Inc., 2011) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K003495.

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 Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033670 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033670: Gore Tri-Lobe Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033670

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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