510(k) · Cleared

Cleared

Cook Coda Balloon Catheter

K032869510(k) TraditionalCleared Nov 19, 200365-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

Cook, Inc. · DQY Catheter, Percutaneous

Cleared on Nov 19, 2003 as substantially equivalent to K002286 (Cook, Inc., 2001) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 2001. 26 later devices descend from it.

Decided: Nov 19, 2003
Review: 65 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K003495 (2001). 2 ancestors in all. 26 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
This deviceK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
Descendant · cites it directly · 11 of its ownK122917 Coda Balloon CatheterCook, Inc. · 2013
Descendant · cites it directly · 11 of its ownK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
Descendant · cites it directly · 10 of its ownK150970 Coda LP Balloon CatheterCook Incorporated · 2015
Descendant · cites it directly · 9 of its ownK151821 ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
Descendant · 2 generations on · 8 of its ownK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2005high 3 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 26 · See all

K122917Coda Balloon CatheterCook, Inc. · 2013 · cites it directly11descendants
K050038Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005 · cites it directly11descendants
K150970Coda LP Balloon CatheterCook Incorporated · 2015 · cites it directly10descendants
K151821ER-REBOA CatheterPryor Medical Devices, Inc. · 2015 · cites it directly9descendants
K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 2 generations on8descendants

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)	K032869	Cook Coda Balloon Catheter	Cook, Inc.	2003	—
+1	K122917	Coda Balloon Catheter	Cook, Inc.	2013	—
+1	K050038	Reliant Stent Graft Balloon Catheter	Medtronic Endovascular Innovations	2005	—
+1	K150970	Coda LP Balloon Catheter	Cook Incorporated	2015	—
+1	K151821	ER-REBOA Catheter	Pryor Medical Devices, Inc.	2015	—
+2	K170411	ER-REBOA Catheter	Prytime Medical Devices, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	2	0
2009	1	0
2010	1	0
2011	1	0
2012	3	0
2013	2	0
2015	2	0
2017	2	0
2018	1	0
2020	3	0
2021	2	0
2022	1	0
2023	1	0
2025	3	0

FIG. 1 — Lineage of K032869, 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? (2)

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
*	K002286	Ldob Occlusion Balloon Catheter Summary page 1 …OON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses. Predicate Devices: Predicate devices are the LDOB BALLOON CATHETER (K002286) manufactured by Cook Incorporated (vessel occlusion), and the ILIAC BALLOON CATHETER (K003495) manufactured by Guidant Corporati…	Cook, Inc.	2001	—
*	K003495	Ancure Lliac Balloon Catheter Summary page 1 …eses. Predicate Devices: Predicate devices are the LDOB BALLOON CATHETER (K002286) manufactured by Cook Incorporated (vessel occlusion), and the ILIAC BALLOON CATHETER (K003495) manufactured by Guidant Corporation (prosthesis expansion). Device Description: The COOK CODATMBALLOON CATHETER is a 2-lumen ca…	Guidant Cardiac and Vascular Surgery	2001	—

Also cleared against K002286: 5 other devices →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K122917	Coda Balloon Catheter	Cook, Inc.	2013	11
K050038	Reliant Stent Graft Balloon Catheter	Medtronic Endovascular Innovations	2005	11
K150970	Coda LP Balloon Catheter	Cook Incorporated	2015	10
K151821	ER-REBOA Catheter	Pryor Medical Devices, Inc.	2015	9
K110891	The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2011	3
K091624	Stent Graft Balloon Catheter	Via Biomedical, Inc.	2009	3
K081799	Gore Tri-Lobe Balloon Catheter	W. L. Gore & Associates, Inc.	2008	2
K101877	Occlusion Balloon Catheter Model Obc	Cook, Inc.	2010	0
K070126	Occlusion Balloon Catheter	Sentreheart, Inc.	2008	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?

None of the 2 ancestors has a recall.
Of its descendants, K122917 (Cook, Inc., 2013) has gone furthest, with 11 descendants of its own.
5 other devices also cite its predicate K002286.

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 COOK CODA BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032869 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032869: Cook Coda Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032869

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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