510(k) · Cleared

Cleared

Vista Brite Tip Catheters

K965211510(k) TraditionalCleared Mar 11, 199774-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 Mar 11, 1997 after a 74-day review. The FDA summary names its predicate without a number. 2 of the 7 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.

Decided: Mar 11, 1997
Review: 74 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 0

6 later devices descend from it, 1 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.

This deviceK965211 Vista Brite Tip CathetersCordis Corp. · 1997
Descendant · cites it directly · 5 of its ownK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
Descendant · 2 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
Descendant · 3 generations on · 1 of its ownK173236 Sentry IVC FilterNovate Medical, Ltd. · 2018
Descendant · 2 generations on · 1 of its ownK091077 Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · Recalled (Class I)
Descendant · 4 generations on · 0 of its ownK181202 Sentry IVC FilterNovate Medical, Ltd. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 2 (2018) · low 0 (2005)2026

Class I recalls in this family

K034050 Cordis Optease Vena Cava Filter, Models…cites it directly · 2004
K091077 Optease Vena Cava Filter and Retrieval Catheter2 generations on · 2010

Most influential descendants

Showing 5 of 6 · See all

K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · cites it directly5descendants
K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 2 generations on2descendants
K173236Sentry IVC FilterNovate Medical, Ltd. · 2018 · 3 generations on1descendant
K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 2 generations on1descendant
K181202Sentry IVC FilterNovate Medical, Ltd. · 2018 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K965211	Vista Brite Tip Catheters	Cordis Corp.	1997	—
+1	K034050	Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable…	Cordis Corporation	2004	Class I
+2	K162875	Sentry IVC filter	Novate Medical, Ltd.	2017	—
+3	K173236	Sentry IVC Filter	Novate Medical, Ltd.	2018	—
+2	K091077	Optease Vena Cava Filter and Retrieval Catheter	Cordis Corp., A Johnson & Johnson Co.	2010	Class I
+4	K181202	Sentry IVC Filter	Novate Medical, Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	1
2010	1	1
2014	1	0
2017	1	0
2018	2	0

FIG. 1 — Lineage of K965211, 1997–2018Source: 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.

2 devices in this family have a Class I recall. 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
*	—	Cordis Vista Brite Tip Named without a submission number			—
*	—	Cordis Endovascular Systems, ENVOY Guiding Catheters Named without a submission number			—

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K034050	Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter… Class I	Cordis Corporation	2004	5

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K034050 (Cordis Corporation, 2004) has gone furthest, with 5 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?

Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

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/K965211 · printed Nov 5, 2026

Cite this page

510(k) Report. “K965211: Vista Brite Tip Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965211

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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